Access Sensitive Estradiol B84493Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 15099590699383), received between Jul 30, 2020 and Apr 7, 2023 — classified as 41 injuries.

The most frequently reported specific device problem is “Low Test Results” (41 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2023Low Test Results; Low Test Results

  ON (B)(6) 2023 THE CUSTOMER REPORTED OBTAINING FALSE LOW SENSITIVE ESTRADIOL (ACCESS SNSE2) RESULTS FOR TWO PATIENT SAMPLES INVOLVING THE LABORATORY'S DXI 800 ACCESS IMMUNOASSAY W/SPOT B ANALYZER (SERIAL NUMBER: (B)(4) ). THE RESULTS WERE QUESTIONED AS NOT MEETING THE CLINICAL PRESENTATION OF THE PATIENTS. THE PATIENTS WERE REPORTED TO BE UNDERGOING EGG STIMULATION (IVF) AND HIGHER ESTRADIOL RESULTS WERE EXPECTED. TWO (2) MEDWATCH REPORTS WILL BE GENERATED TO ADDRESS CUSTOMER REPORTS OF DELAY TO TREATMENT FOR TWO DIFFERENT PATIENTS. THIS REPORT WILL ADDRESS PATIENT TWO. THE QUESTIONED SNSE2 PATIENT 2 SAMPLE RESULTS WERE AT 675.26 PG/ML, REPEATED AT 672.08 PG/ML ON (B)(6) 2023. THE SAMPLE WAS RUN ON AN ALTERNATE INSTRUMENT PLATFORM (ROCHE COBAS) AND A HIGHER RESULT WAS OBTAINED AT 894.4 PG/ML. RANGE OF RESULTS EXPECTED ON THE ALTERNATE INSTRUMENT PLATFORM WAS NOT SPECIFIED IN THIS EVENT. ON (B)(6) 2023, THE CUSTOMER REPORTED IVF (IN VITRO FERTILIZATION) TREATMENT WAS DELAYED IN CONNECTION WITH THE LOW SNSE2 RESULTS. THE CUSTOMER REPORTED THE TREATMENT WAS DELAYED AS THE LABORATORY WAS WAITING FOR RESULTS FROM THE ALTERNATE SITE. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE RE

  Patient problems: Insufficient Information

  MAUDE report 16699184 ↗
• InjuryApr 7, 2023Low Test Results; Low Test Results

  ON 10MAR2023 THE CUSTOMER REPORTED OBTAINING FALSE LOW SENSITIVE ESTRADIOL (ACCESS SNSE2) RESULTS FOR TWO PATIENT SAMPLES INVOLVING THE LABORATORY'S DXI 800 ACCESS IMMUNOASSAY W/SPOT B ANALYZER (SERIAL NUMBER (B)(4)). THE RESULTS WERE QUESTIONED AS NOT MEETING THE CLINICAL PRESENTATION OF THE PATIENTS. THE PATIENTS WERE REPORTED TO BE UNDERGOING EGG STIMULATION (IVF) AND HIGHER ESTRADIOL RESULTS WERE EXPECTED. TWO (2) MEDWATCH REPORTS WILL BE GENERATED TO ADDRESS CUSTOMER REPORTS OF DELAY TO TREATMENT FOR TWO DIFFERENT PATIENTS. THIS REPORT WILL ADDRESS PATIENT ONE. ON (B)(6) 2023, THE QUESTIONED SNSE2 PATIENT 1 SAMPLE RESULTS WERE AT 877.11 PG/ML, REPEATED AT 919.02 PG/ML AND AT 945.78 PG/ML. THE RESULTS WERE ALSO QUESTIONED AS AN SNSE2 RESULT OF 1052.98 PG/ML WAS PREVIOUSLY OBTAINED AFTER AN IVF INJECTION. AN INCREASE IN SNSE2 RECOVERY WAS EXPECTED WHEN RUNNING A NEW SAMPLE FROM THE PATIENT ON (B)(6) 2023. THE SAMPLE QUESTIONED WAS RUN ON AN ALTERNATE INSTRUMENT PLATFORM (ROCHE COBAS) AND A HIGHER RESULT WAS OBTAINED AT 3077 PG/ML. RANGE OF RESULTS EXPECTED ON THE ALTERNATE INSTRUMENT PLATFORM WAS NOT SPECIFIED IN THIS EVENT. ON 26MAR2023, THE CUSTOMER REPORTED IVF (IN VITRO FERT

  Patient problems: Insufficient Information

  MAUDE report 16699168 ↗
• InjurySep 24, 2021Low Test Results; Low Test Results

  ON (B)(6) 2021 THE CUSTOMER REPORTED OBTAINING FALSE LOW SENSITIVE ESTRADIOL (ACCESS SNSE2) RESULTS INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(4)). ON (B)(6) 2021, THE FIRST PATIENT¿S RESULT WAS 1222.20 PG/ML (NOT QUESTIONED). ON (B)(6) 2021, A NEW COLLECTED SAMPLE GAVE A SNSE2 RESULT AT 356.37 PG/ML THAT WAS DISCORDANT WITH CUSTOMER EXPECTATION. THE CUSTOMER DILUTED IT ½ WITH S0 CALIBRATOR AND OBTAINED A RESULT AT 1152.86 PG/ML ON (B)(6) 2021, HE DILUTED IT AT 1/5 AND THE RESULT WAS 12226.06 PG/ML ON (B)(6) 2021. THIS SAMPLE WAS RETESTED WITH THE ROCHE COBAS METHOD AND THE RESULT WAS DISCORDANT AT 1475.00 PG/ML. THE SAMPLE WAS ALSO REPEATED ON DXI INSTRUMENT WITH E2 REAGENT AND A HIGHER RESULT AT 1561.1 PG/ML WAS ALSO OBTAINED ON (B)(6) 2021. A THIRD SAMPLE WAS COLLECTED ON (B)(6) 2021 AND THE SNSE2 RESULT WAS 610.14 PG/ML. THIS SAMPLE WAS RETESTED WITH THE ROCHE COBAS METHOD, THE RESULT WAS 826.00 PG/ML. THE SAMPLE WAS REPEATED ON DXI INSTRUMENT WITH E2 REAGENT AND A HIGHER RESULT AT 958.0 PG/ML WAS OBTAINED ON (B)(6) 2021. THE PATIENT WAS UNDER OVARIAN FUNCTIONAL STIMULATION (THE CUSTOMER¿S EXPECTED RANGES FOR PATIENTS UNDER STIMULATION TREATMENT

  Patient problems: Insufficient Information

  MAUDE report 12524856 ↗
• InjuryJul 21, 2021Low Test Results; Low Test Results

  ON (B)(6) 2021, THE CUSTOMER REPORTED OBTAINING UNEXPECTED LOW SENSITIVE ESTRADIOL (ACCESS SNSE2, PART NUMBER B84493, LOT NUMBER 966030) PATIENT RESULTS INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100, SERIAL NUMBER (B)(4)). ON (B)(6) 2021, THE INITIAL SNSE2 PATIENT RESULT WAS UNEXPECTED LOW AT 11.8 PG/ML (SNSE2 REPORTABLE RANGE IS 15.0 PG/ML) WHICH WAS DISCORDANT WITH THE B-MODE ULTRASOUND RESULT AND HISTORICAL PATIENT DATA. INDEED ON (B)(6) 2021 THE ACCESS ESTRADIOL E2 (PART NUMBER 33540) PATIENT RESULT WAS 37 PG/ML. BASED ON THE LOW ACCESS SNSE2 RESULT, THE PATIENT WAS INTAKE ESTRADIOL VALERATE TABLETS: PROGYNOVA. THE PATIENT WHO IS A (B)(6) YEARS¿ FEMALE WAS IN PERIMENOPAUSE AND HAD ABNORMAL UTERINE BLEEDING. AFTER 15 DAYS OF PROGYNOVA, THE PATIENT WAS RETESTED ON (B)(6) 2021 AND THE SNSE2 PATIENT RESULT WAS SIMILAR LOW AT 13.22 PG/ML. UPON REPEAT (SAME SAMPLE) THE SNSE2 RESULT WAS AT 7.57 PG/ML. THESE ACCESS SNSE2 RESULTS WERE AGAIN DISCORDANT WITH THE NEW B-MODE ULTRASOUND RESULT PERFORMED. THE DAY AFTER, ON (B)(6) 2021, THE SAME SAMPLE PATIENT WAS RETESTED ON ANOTHER BECKMAN COULTER ANALYZER WITH A LOWER SNSE2 RESULT (0 PG/ML), AND O

  Patient problems: Insufficient Information

  MAUDE report 12201642 ↗
• InjuryJul 21, 2021Low Test Results; Low Test Results

  ON (B)(6) 2021, THE CUSTOMER REPORTED OBTAINING UNEXPECTED LOW SENSITIVE ESTRADIOL (ACCESS SNSE2, PART NUMBER B84493, LOT NUMBER 966030) PATIENT RESULTS INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100, SERIAL NUMBER (B)(4)). ON (B)(6) 2021, THE INITIAL SNSE2 PATIENT RESULT WAS UNEXPECTED LOW AT 11.8 PG/ML (SNSE2 REPORTABLE RANGE IS 15.0 PG/ML) WHICH WAS DISCORDANT WITH THE B-MODE ULTRASOUND RESULT AND HISTORICAL PATIENT DATA. INDEED ON (B)(6) 2021 THE ACCESS ESTRADIOL E2 (PART NUMBER 33540) PATIENT RESULT WAS 37 PG/ML. BASED ON THE LOW ACCESS SNSE2 RESULT, THE PATIENT WAS INTAKE ESTRADIOL VALERATE TABLETS: PROGYNOVA. THE PATIENT WHO IS A (B)(6) YEARS¿ FEMALE WAS IN PERIMENOPAUSE AND HAD ABNORMAL UTERINE BLEEDING. AFTER 15 DAYS OF PROGYNOVA, THE PATIENT WAS RETESTED ON (B)(6) 2021 AND THE SNSE2 PATIENT RESULT WAS SIMILAR LOW AT 13.22 PG/ML. UPON REPEAT (SAME SAMPLE) THE SNSE2 RESULT WAS AT 7.57 PG/ML. THESE ACCESS SNSE2 RESULTS WERE AGAIN DISCORDANT WITH THE NEW B-MODE ULTRASOUND RESULT PERFORMED. THE DAY AFTER, ON (B)(6) 2021, THE SAME SAMPLE PATIENT WAS RETESTED ON ANOTHER BECKMAN COULTER ANALYZER WITH A LOWER SNSE2 RESULT (0 PG/ML), AND O

  Patient problems: Insufficient Information

  MAUDE report 12201641 ↗
• InjurySep 16, 2020Low Test Results; Low Test Results

  ON (B)(6) 2020 THE CUSTOMER REPORTED OBTAINING FALSE LOW SENSITIVE ESTRADIOL (ACCESS SNSE2) RESULTS INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNO ANALYZER (SERIAL NUMBER (B)(4)). CUSTOMER REPORTED THAT BEFORE AND AFTER ESTRADIOL MEDICATION, THERE WAS NO CHANGE IN THE SNSE2 RESULTS, WHICH AFFECTED CLINICAL JUDGMENT. A BECKMAN COULTER LABORATORY SOLUTION SPECIALIST (LSS) WAS DISPATCHED TO THE CUSTOMER SITE ON 03SEP2020 TO PERFORM COMPARISON TESTING WITH THE ACCESS ESTRADIOL (E2) ASSAY AND ON AN ALTERNATE METHODOLOGY MANUFACTURED BY ROCHE. ON 02SEP2020, THE INITIAL SNSE2 PATIENT SAMPLE RESULT WAS 157 PG/ML WHICH WAS UNEXPECTED LOW AND DISCORDANT WITH THE CLINICAL EXPECTATION. ON 03SEP2020, THIS SAMPLE WAS RETESTED WITH THE ACCESS E2 ASSAY ON ANOTHER INSTRUMENT (SERIAL NUMBER (B)(4)) WITH A RESULT OF 175 PG/ML (644 PMOL/L) AND ON THE ROCHE PLATFORM WITH AN ESTRADIOL RESULT OF 246 PG/ML (903 PMOL/L). BOTH RESULTS WERE HIGHER AND MORE ACCORDANT WITH THE CLINICAL EXPECTATION. THE EXPECTED OR CORRECT RESULTS WERE NOT SPECIFIED IN THIS EVENT. BASED ON THE LOW SNSE2 RESULT OBTAINED DURING FOLLICULAR MONITORING, THE PATIENT WAS INTAKE OVER-DOSE MEDICINE (ESTRADIOL VALERATE TABLETS:

  Patient problems: Overdose

  MAUDE report 10539472 ↗
• InjurySep 16, 2020Low Test Results; Low Test Results

  ON (B)(6) 2020 THE CUSTOMER REPORTED OBTAINING FALSE LOW SENSITIVE ESTRADIOL (ACCESS SNSE2) RESULTS INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNO ANALYZER (SERIAL NUMBER (B)(4)). CUSTOMER REPORTED THAT BEFORE AND AFTER ESTRADIOL MEDICATION, THERE WAS NO CHANGE IN THE SNSE2 RESULTS, WHICH AFFECTED CLINICAL JUDGMENT. A BECKMAN COULTER LABORATORY SOLUTION SPECIALIST (LSS) WAS DISPATCHED TO THE CUSTOMER SITE ON 03SEP2020 TO PERFORM COMPARISON TESTING WITH THE ACCESS ESTRADIOL (E2) ASSAY AND ON AN ALTERNATE METHODOLOGY MANUFACTURED BY ROCHE. ON (B)(6) 2020, THE INITIAL (B)(4) PATIENT SAMPLE RESULT WAS 129 PG/ML WHICH WAS UNEXPECTED LOW AND DISCORDANT WITH THE CLINICAL EXPECTATION. ON (B)(6) 2020, THIS SAMPLE WAS RETESTED WITH THE ACCESS E2 ASSAY ON ANOTHER INSTRUMENT (SERIAL NUMBER (B)(4)) WITH A RESULT OF 339 PG/ML (1245 PMOL/L) AND ON THE ROCHE PLATFORM WITH AN ESTRADIOL RESULT OF 209 PG/ML (767.7 PMOL/L). BOTH RESULTS WERE HIGHER AND MORE ACCORDANT WITH THE CLINICAL EXPECTATION. THE EXPECTED OR CORRECT RESULTS WERE NOT SPECIFIED IN THIS EVENT. BASED ON THE LOW SNSE2 RESULT OBTAINED DURING FOLLICULAR MONITORING, THE PATIENT WAS INTAKE OVER-DOSE MEDICINE (ESTRADIOL VALERATE T

  Patient problems: Overdose

  MAUDE report 10539378 ↗
• InjurySep 16, 2020Low Test Results; Low Test Results

  ON (B)(6) 2020 THE CUSTOMER REPORTED OBTAINING FALSE LOW SENSITIVE ESTRADIOL (ACCESS SNSE2) RESULTS INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNO ANALYZER (SERIAL NUMBER (B)(4)). CUSTOMER REPORTED THAT BEFORE AND AFTER ESTRADIOL MEDICATION, THERE WAS NO CHANGE IN THE SNSE2 RESULTS, WHICH AFFECTED CLINICAL JUDGMENT. A BECKMAN COULTER LABORATORY SOLUTION SPECIALIST (LSS) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(6) 2020 TO PERFORM COMPARISON TESTING WITH THE ACCESS ESTRADIOL (E2) ASSAY AND ON AN ALTERNATE METHODOLOGY MANUFACTURED BY ROCHE. ON (B)(6) 2020, THE INITIAL SNSE2 PATIENT SAMPLE RESULT WAS 90 PG/ML WHICH WAS UNEXPECTED LOW AND DISCORDANT WITH THE CLINICAL EXPECTATION. ON (B)(6) 2020, THIS SAMPLE WAS RETESTED WITH THE ACCESS E2 ASSAY ON ANOTHER INSTRUMENT (SERIAL NUMBER (B)(4)) WITH A RESULT OF 272 PG/ML (997 PMOL/L) AND ON THE ROCHE PLATFORM WITH AN ESTRADIOL RESULT OF 134 PG/ML (492 PMOL/L). BOTH RESULTS WERE HIGHER AND MORE ACCORDANT WITH THE CLINICAL EXPECTATION. THE EXPECTED OR CORRECT RESULTS WERE NOT SPECIFIED IN THIS EVENT. BASED ON THE LOW SNSE2 RESULT OBTAINED DURING FOLLICULAR MONITORING, THE PATIENT WAS INTAKE OVER-DOSE MEDICINE (ESTRADIOL VALERATE TABL

  Patient problems: Overdose

  MAUDE report 10539377 ↗
• InjurySep 16, 2020Low Test Results; Low Test Results

  ON 02SEP2020, THE CUSTOMER REPORTED OBTAINING FALSE LOW SENSITIVE ESTRADIOL (ACCESS SNSE2) RESULT FOR MULTIPLE PATIENTS INVOLVING THE LABORATORY'S UNICEL DXI 800 ACCESS IMMUNO ANALYZER (SERIAL NUMBER (B)(4)). CUSTOMER REPORTED THAT BEFORE AND AFTER ESTRADIOL MEDICATION, THERE WAS NO CHANGE IN THE SNSE2 RESULTS, WHICH AFFECTED CLINICAL JUDGMENT. PER BECKMAN COULTER LABORATORY SOLUTION SPECIALIST (LSS) VERBAL'S REPORT, AROUND TEN PATIENTS WERE INVOLVED IN THIS ISSUE. ONLY THREE PATIENT RESULTS WERE PROVIDED BY CUSTOMER BUT ARE EXCLUDED FROM THIS REPORT AS THREE MDRS HAVE BEEN ALREADY SUBMITTED FOR THESE THREE PATIENTS. NO FURTHER PATIENT INFORMATION WAS PROVIDED. BASED ON THE LOW SNSE2 RESULT OBTAINED DURING FOLLICULAR MONITORING, THE PATIENTS WERE INTAKE OVER-DOSE MEDICINE (ESTRADIOL VALERATE TABLETS: PROGYNOVA). SNSE2 CALIBRATION WAS PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. PER CUSTOMER¿S VERBAL REPORT, SYSTEM CHECKS HAVE BEEN PASSING AND QC WAS WITHIN THE LABORATORY¿S ESTABLISHED RANGES. ADDITIONALLY, NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SAMPLE TUBE COLLECTION TYPE WAS NOT PROVIDED. SAMPLE PROCESSING INFORMATION SUCH

  Patient problems: Overdose

  MAUDE report 10539375 ↗
• InjuryJul 31, 2020Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED LOW SENSITIVE ESTRADIOL (ACCESS SENSITIVE ESTRADIOL) RESULTS WHICH HAD BEEN GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER REPORTED ON 09JULY2020 THAT BASED ON THE QUESTIONED LOW SENSITIVE ESTRADIOL RESULT THERE WAS A DELAY IN PATIENT TREATMENT; SPECIFICALLY, A DELAY IN ADMINISTERING IVF (IN-VITRO FERTILIZATION) THERAPY MEDICATIONS OF FOLLITROPIN ALFA (GONAL-F) AND MENOTROPINS (MENOPUR). THERE WAS NO ADDITIONAL REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTED TESTING ONE SAMPLE DRAWN FROM THE PATIENT. THE SAMPLE WAS TESTED TWO TIMES. SYSTEM PERFORMANCE INDICATORS SUCH AS QUALITY CONTROL AND CALIBRATIONS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ALTHOUGH THE CUSTOMER REPORTED A FAILING SYSTEM CHECK, THEY REPORTED A SUBSEQUENT SYSTEM CHECK REPEATED THE SAME DAY PASSED WITHIN SPECIFICATIONS; THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION; ADDITIONALLY, THERE WERE NO REPORTS OF SYSTEMIC ISSUES SUCH AS IMPACT TO OTHER ASSAYS IN CONNECTION WITH THIS EVENT. SAMPLES WAS COLLECTED IN A BECTON DICKINSON (BD) GEL PLASMA TUBE. INFORMATION REGAR

  Patient problems: No Code Available

  MAUDE report 10349317 ↗
• InjuryJul 31, 2020Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED LOW SENSITIVE ESTRADIOL (ACCESS SENSITIVE ESTRADIOL) RESULTS WHICH HAD BEEN GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER REPORTED ON 09JULY2020 THAT BASED ON THE QUESTIONED LOW SENSITIVE ESTRADIOL RESULT THERE WAS A DELAY IN PATIENT TREATMENT; SPECIFICALLY, A DELAY IN ADMINISTERING IVF (IN-VITRO FERTILIZATION) THERAPY MEDICATIONS OF FOLLITROPIN ALFA (GONAL-F) AND MENOTROPINS (MENOPUR). THERE WAS NO ADDITIONAL REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTED TESTING ONE SAMPLE DRAWN FROM THE PATIENT. THE SAMPLE WAS TESTED THREE TIMES. SYSTEM PERFORMANCE INDICATORS SUCH AS QUALITY CONTROL AND CALIBRATIONS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ALTHOUGH THE CUSTOMER REPORTED A FAILING SYSTEM CHECK, THEY REPORTED A SUBSEQUENT SYSTEM CHECK REPEATED THE SAME DAY PASSED WITHIN SPECIFICATIONS; THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION; ADDITIONALLY, THERE WERE NO REPORTS OF SYSTEMIC ISSUES SUCH AS IMPACT TO OTHER ASSAYS IN CONNECTION WITH THIS EVENT. SAMPLES WAS COLLECTED IN A BECTON DICKINSON (BD) GEL PLASMA TUBE. INFORMATION REG

  Patient problems: No Code Available

  MAUDE report 10349315 ↗
• InjuryJul 31, 2020Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED LOW SENSITIVE ESTRADIOL (ACCESS SENSITIVE ESTRADIOL) RESULTS WHICH HAD BEEN GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER REPORTED ON 09JULY2020 THAT BASED ON THE QUESTIONED LOW SENSITIVE ESTRADIOL RESULT THERE WAS A DELAY IN PATIENT TREATMENT; SPECIFICALLY, A DELAY IN ADMINISTERING IVF (IN-VITRO FERTILIZATION) THERAPY MEDICATIONS OF FOLLITROPIN ALFA (GONAL-F) AND MENOTROPINS (MENOPUR). THERE WAS NO ADDITIONAL REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTED TESTING ONE SAMPLE DRAWN FROM THE PATIENT. THE SAMPLE WAS TESTED THREE TIMES. SYSTEM PERFORMANCE INDICATORS SUCH AS QUALITY CONTROL AND CALIBRATIONS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ALTHOUGH THE CUSTOMER REPORTED A FAILING SYSTEM CHECK, THEY REPORTED A SUBSEQUENT SYSTEM CHECK REPEATED THE SAME DAY PASSED WITHIN SPECIFICATIONS; THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION; ADDITIONALLY, THERE WERE NO REPORTS OF SYSTEMIC ISSUES SUCH AS IMPACT TO OTHER ASSAYS IN CONNECTION WITH THIS EVENT. SAMPLES WAS COLLECTED IN A BECTON DICKINSON (BD) GEL PLASMA TUBE. INFORMATION REG

  Patient problems: No Code Available

  MAUDE report 10349314 ↗
• InjuryJul 31, 2020Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED LOW SENSITIVE ESTRADIOL (ACCESS SENSITIVE ESTRADIOL) RESULTS WHICH HAD BEEN GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER REPORTED ON 09JULY2020 THAT BASED ON THE QUESTIONED LOW SENSITIVE ESTRADIOL RESULT THERE WAS A DELAY IN PATIENT TREATMENT; SPECIFICALLY, A DELAY IN ADMINISTERING IVF (IN-VITRO FERTILIZATION) THERAPY MEDICATIONS OF FOLLITROPIN ALFA (GONAL-F) AND MENOTROPINS (MENOPUR). THERE WAS NO ADDITIONAL REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTED TESTING ONE SAMPLE DRAWN FROM THE PATIENT. THE SAMPLE WAS TESTED ON TWO SEPARATE DAYS. SYSTEM PERFORMANCE INDICATORS SUCH AS QUALITY CONTROL AND CALIBRATIONS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ALTHOUGH THE CUSTOMER REPORTED A FAILING SYSTEM CHECK, THEY REPORTED A SUBSEQUENT SYSTEM CHECK REPEATED THE SAME DAY PASSED WITHIN SPECIFICATIONS; THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION; ADDITIONALLY, THERE WERE NO REPORTS OF SYSTEMIC ISSUES SUCH AS IMPACT TO OTHER ASSAYS IN CONNECTION WITH THIS EVENT. SAMPLE WAS COLLECTED IN A BECTON DICKINSON (BD) GEL PLASMA TUBE. INFORMA

  Patient problems: No Code Available

  MAUDE report 10349302 ↗
• InjuryJul 31, 2020Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED LOW SENSITIVE ESTRADIOL (ACCESS SENSITIVE ESTRADIOL) RESULTS WHICH HAD BEEN GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER REPORTED ON 09JULY2020 THAT BASED ON THE QUESTIONED LOW SENSITIVE ESTRADIOL RESULT THERE WAS A DELAY IN PATIENT TREATMENT; SPECIFICALLY, A DELAY IN ADMINISTERING IVF (IN-VITRO FERTILIZATION) THERAPY MEDICATIONS OF FOLLITROPIN ALFA (GONAL-F) AND MENOTROPINS (MENOPUR). THERE WAS NO ADDITIONAL REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTED TESTING ONE SAMPLE DRAWN FROM THE PATIENT OVER TWO DAYS. SYSTEM PERFORMANCE INDICATORS SUCH AS QUALITY CONTROL AND CALIBRATIONS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ALTHOUGH THE CUSTOMER REPORTED A FAILING SYSTEM CHECK, THEY REPORTED A SUBSEQUENT SYSTEM CHECK REPEATED THE SAME DAY PASSED WITHIN SPECIFICATIONS; THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION; ADDITIONALLY, THERE WERE NO REPORTS OF SYSTEMIC ISSUES SUCH AS IMPACT TO OTHER ASSAYS IN CONNECTION WITH THIS EVENT. SAMPLE WAS COLLECTED IN BECTON DICKINSON (BD) GEL SERUM TUBE. INFORMATION REGARDING TUBE MANUFACTURER,

  Patient problems: No Code Available

  MAUDE report 10349301 ↗
• InjuryJul 31, 2020Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED LOW SENSITIVE ESTRADIOL (ACCESS SENSITIVE ESTRADIOL) RESULTS WHICH HAD BEEN GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER REPORTED ON 09JULY2020 THAT BASED ON THE QUESTIONED LOW SENSITIVE ESTRADIOL RESULT THERE WAS A DELAY IN PATIENT TREATMENT; SPECIFICALLY, A DELAY IN ADMINISTERING IVF (IN-VITRO FERTILIZATION) THERAPY MEDICATIONS OF FOLLITROPIN ALFA (GONAL-F) AND MENOTROPINS (MENOPUR). THERE WAS NO ADDITIONAL REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTED TESTING ONE SAMPLE DRAWN FROM THE PATIENT OVER TWO DAYS. SYSTEM PERFORMANCE INDICATORS SUCH AS QUALITY CONTROL AND CALIBRATIONS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ALTHOUGH THE CUSTOMER REPORTED A FAILING SYSTEM CHECK, THEY REPORTED A SUBSEQUENT SYSTEM CHECK REPEATED THE SAME DAY PASSED WITHIN SPECIFICATIONS; THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION; ADDITIONALLY, THERE WERE NO REPORTS OF SYSTEMIC ISSUES SUCH AS IMPACT TO OTHER ASSAYS IN CONNECTION WITH THIS EVENT. SAMPLE WAS COLLECTED IN BECTON DICKINSON (BD) GEL PLASMA TUBE. INFORMATION REGARDING TUBE MANUFACTURER

  Patient problems: No Code Available

  MAUDE report 10349299 ↗
• InjuryJul 31, 2020Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED LOW SENSITIVE ESTRADIOL (ACCESS SENSITIVE ESTRADIOL) RESULTS WHICH HAD BEEN GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER REPORTED ON 09JULY2020 THAT BASED ON THE QUESTIONED LOW SENSITIVE ESTRADIOL RESULT THERE WAS A DELAY IN PATIENT TREATMENT; SPECIFICALLY, A DELAY IN ADMINISTERING IVF (IN-VITRO FERTILIZATION) THERAPY MEDICATIONS OF FOLLITROPIN ALFA (GONAL-F) AND MENOTROPINS (MENOPUR). THERE WAS NO ADDITIONAL REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTED TESTING ONE SAMPLE DRAWN FROM THE PATIENT. THE SAMPLE WAS TESTED ON TWO DIFFERENT DAYS. SYSTEM PERFORMANCE INDICATORS SUCH AS QUALITY CONTROL AND CALIBRATIONS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ALTHOUGH THE CUSTOMER REPORTED A FAILING SYSTEM CHECK, THEY REPORTED A SUBSEQUENT SYSTEM CHECK REPEATED THE SAME DAY PASSED WITHIN SPECIFICATIONS; THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION; ADDITIONALLY, THERE WERE NO REPORTS OF SYSTEMIC ISSUES SUCH AS IMPACT TO OTHER ASSAYS IN CONNECTION WITH THIS EVENT. SAMPLE WAS COLLECTED IN A BECTON DICKINSON (BD) GEL PLASMA TUBE. INFORM

  Patient problems: No Code Available

  MAUDE report 10349298 ↗
• InjuryJul 31, 2020Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED LOW SENSITIVE ESTRADIOL (ACCESS SENSITIVE ESTRADIOL) RESULTS WHICH HAD BEEN GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER REPORTED ON 09JULY2020 THAT BASED ON THE QUESTIONED LOW SENSITIVE ESTRADIOL RESULT THERE WAS A DELAY IN PATIENT TREATMENT; SPECIFICALLY, A DELAY IN ADMINISTERING IVF (IN-VITRO FERTILIZATION) THERAPY MEDICATIONS OF FOLLITROPIN ALFA (GONAL-F) AND MENOTROPINS (MENOPUR). THERE WAS NO ADDITIONAL REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTED TESTING ONE SAMPLE DRAWN FROM THE PATIENT. THE SAMPLE WAS TESTED ONE TIME. SYSTEM PERFORMANCE INDICATORS SUCH AS QUALITY CONTROL AND CALIBRATIONS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ALTHOUGH THE CUSTOMER REPORTED A FAILING SYSTEM CHECK, THEY REPORTED A SUBSEQUENT SYSTEM CHECK REPEATED THE SAME DAY PASSED WITHIN SPECIFICATIONS; THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION; ADDITIONALLY, THERE WERE NO REPORTS OF SYSTEMIC ISSUES SUCH AS IMPACT TO OTHER ASSAYS IN CONNECTION WITH THIS EVENT. SAMPLES WAS COLLECTED IN A BECTON DICKINSON (BD) GEL PLASMA TUBE. INFORMATION REGARD

  Patient problems: No Code Available

  MAUDE report 10349297 ↗
• InjuryJul 31, 2020Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED LOW SENSITIVE ESTRADIOL (ACCESS SENSITIVE ESTRADIOL) RESULTS WHICH HAD BEEN GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER REPORTED ON 09JULY2020 THAT BASED ON THE QUESTIONED LOW SENSITIVE ESTRADIOL RESULT THERE WAS A DELAY IN PATIENT TREATMENT; SPECIFICALLY, A DELAY IN ADMINISTERING IVF (IN-VITRO FERTILIZATION) THERAPY MEDICATIONS OF FOLLITROPIN ALFA (GONAL-F) AND MENOTROPINS (MENOPUR). THERE WAS NO ADDITIONAL REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTED TESTING ONE SAMPLE DRAWN FROM THE PATIENT OVER TWO DAYS. SYSTEM PERFORMANCE INDICATORS SUCH AS QUALITY CONTROL AND CALIBRATIONS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ALTHOUGH THE CUSTOMER REPORTED A FAILING SYSTEM CHECK, THEY REPORTED A SUBSEQUENT SYSTEM CHECK REPEATED THE SAME DAY PASSED WITHIN SPECIFICATIONS; THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION; ADDITIONALLY, THERE WERE NO REPORTS OF SYSTEMIC ISSUES SUCH AS IMPACT TO OTHER ASSAYS IN CONNECTION WITH THIS EVENT. SAMPLE WAS COLLECTED IN BECTON DICKINSON (BD) GEL PLASMA TUBE. INFORMATION REGARDING TUBE MANUFACTURER

  Patient problems: No Code Available

  MAUDE report 10349257 ↗
• InjuryJul 31, 2020Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED LOW SENSITIVE ESTRADIOL (ACCESS SENSITIVE ESTRADIOL) RESULTS WHICH HAD BEEN GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER REPORTED ON 09JULY2020 THAT BASED ON THE QUESTIONED LOW SENSITIVE ESTRADIOL RESULT THERE WAS A DELAY IN PATIENT TREATMENT; SPECIFICALLY, A DELAY IN ADMINISTERING IVF (IN-VITRO FERTILIZATION) THERAPY MEDICATIONS OF FOLLITROPIN ALFA (GONAL-F) AND MENOTROPINS (MENOPUR). THERE WAS NO ADDITIONAL REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTED TESTING ONE SAMPLE DRAWN FROM THE PATIENT OVER TWO DAYS. SYSTEM PERFORMANCE INDICATORS SUCH AS QUALITY CONTROL AND CALIBRATIONS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ALTHOUGH THE CUSTOMER REPORTED A FAILING SYSTEM CHECK, THEY REPORTED A SUBSEQUENT SYSTEM CHECK REPEATED THE SAME DAY PASSED WITHIN SPECIFICATIONS; THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION; ADDITIONALLY, THERE WERE NO REPORTS OF SYSTEMIC ISSUES SUCH AS IMPACT TO OTHER ASSAYS IN CONNECTION WITH THIS EVENT. SAMPLE WAS COLLECTED IN BECTON DICKINSON (BD) GEL SERUM TUBE. INFORMATION REGARDING TUBE MANUFACTURER,

  Patient problems: No Code Available

  MAUDE report 10349254 ↗
• InjuryJul 31, 2020Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED LOW SENSITIVE ESTRADIOL (ACCESS SENSITIVE ESTRADIOL) RESULTS WHICH HAD BEEN GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER REPORTED ON 09JULY2020 THAT BASED ON THE QUESTIONED LOW SENSITIVE ESTRADIOL RESULT THERE WAS A DELAY IN PATIENT TREATMENT; SPECIFICALLY, A DELAY IN ADMINISTERING IVF (IN-VITRO FERTILIZATION) THERAPY MEDICATIONS OF FOLLITROPIN ALFA (GONAL-F) AND MENOTROPINS (MENOPUR). THERE WAS NO ADDITIONAL REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTED TESTING ONE SAMPLE DRAWN FROM THE PATIENT TWICE ON THE SAME DAY. SYSTEM PERFORMANCE INDICATORS SUCH AS QUALITY CONTROL AND CALIBRATIONS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ALTHOUGH THE CUSTOMER REPORTED A FAILING SYSTEM CHECK, THEY REPORTED A SUBSEQUENT SYSTEM CHECK REPEATED THE SAME DAY PASSED WITHIN SPECIFICATIONS; THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION; ADDITIONALLY, THERE WERE NO REPORTS OF SYSTEMIC ISSUES SUCH AS IMPACT TO OTHER ASSAYS IN CONNECTION WITH THIS EVENT. SAMPLE WAS COLLECTED IN BECTON DICKINSON (BD) GEL PLASMA TUBE. INFORMATION REGARDING TUBE MANU

  Patient problems: No Code Available

  MAUDE report 10349253 ↗
• InjuryJul 31, 2020Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED LOW SENSITIVE ESTRADIOL (ACCESS SENSITIVE ESTRADIOL) RESULTS WHICH HAD BEEN GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER REPORTED ON 09JULY2020 THAT BASED ON THE QUESTIONED LOW SENSITIVE ESTRADIOL RESULT THERE WAS A DELAY IN PATIENT TREATMENT; SPECIFICALLY, A DELAY IN ADMINISTERING IVF (IN-VITRO FERTILIZATION) THERAPY MEDICATIONS OF FOLLITROPIN ALFA (GONAL-F) AND MENOTROPINS (MENOPUR). THERE WAS NO ADDITIONAL REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTED TESTING ONE SAMPLE DRAWN FROM THE PATIENT TWICE ON THE SAME DAY. SYSTEM PERFORMANCE INDICATORS SUCH AS QUALITY CONTROL AND CALIBRATIONS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ALTHOUGH THE CUSTOMER REPORTED A FAILING SYSTEM CHECK, THEY REPORTED A SUBSEQUENT SYSTEM CHECK REPEATED THE SAME DAY PASSED WITHIN SPECIFICATIONS; THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION; ADDITIONALLY, THERE WERE NO REPORTS OF SYSTEMIC ISSUES SUCH AS IMPACT TO OTHER ASSAYS IN CONNECTION WITH THIS EVENT. SAMPLE WAS COLLECTED IN BECTON DICKINSON (BD) GEL PLASMA TUBE. INFORMATION REGARDING TUBE MANU

  Patient problems: No Code Available

  MAUDE report 10349252 ↗
• InjuryJul 31, 2020Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED LOW SENSITIVE ESTRADIOL (ACCESS SENSITIVE ESTRADIOL) RESULTS WHICH HAD BEEN GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER REPORTED ON 09JULY2020 THAT BASED ON THE QUESTIONED LOW SENSITIVE ESTRADIOL RESULT THERE WAS A DELAY IN PATIENT TREATMENT; SPECIFICALLY, A DELAY IN ADMINISTERING IVF (IN-VITRO FERTILIZATION) THERAPY MEDICATIONS OF FOLLITROPIN ALFA (GONAL-F) AND MENOTROPINS (MENOPUR). THERE WAS NO ADDITIONAL REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTED TESTING ONE SAMPLE DRAWN FROM THE PATIENT TWICE ON THE SAME DAY. SYSTEM PERFORMANCE INDICATORS SUCH AS QUALITY CONTROL AND CALIBRATIONS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ALTHOUGH THE CUSTOMER REPORTED A FAILING SYSTEM CHECK, THEY REPORTED A SUBSEQUENT SYSTEM CHECK REPEATED THE SAME DAY PASSED WITHIN SPECIFICATIONS; THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION; ADDITIONALLY, THERE WERE NO REPORTS OF SYSTEMIC ISSUES SUCH AS IMPACT TO OTHER ASSAYS IN CONNECTION WITH THIS EVENT. SAMPLE WAS COLLECTED IN BECTON DICKINSON (BD) GEL PLASMA TUBE. INFORMATION REGARDING TUBE MANU

  Patient problems: No Code Available

  MAUDE report 10349250 ↗
• InjuryJul 31, 2020Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED LOW SENSITIVE ESTRADIOL (ACCESS SENSITIVE ESTRADIOL) RESULTS WHICH HAD BEEN GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER REPORTED ON 09JULY2020 THAT BASED ON THE QUESTIONED LOW SENSITIVE ESTRADIOL RESULT THERE WAS A DELAY IN PATIENT TREATMENT; SPECIFICALLY, A DELAY IN ADMINISTERING IVF (IN-VITRO FERTILIZATION) THERAPY MEDICATIONS OF FOLLITROPIN ALFA (GONAL-F) AND MENOTROPINS (MENOPUR). THERE WAS NO ADDITIONAL REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTED TESTING ONE SAMPLE DRAWN FROM THE PATIENT OVER TWO DAYS. SYSTEM PERFORMANCE INDICATORS SUCH AS QUALITY CONTROL AND CALIBRATIONS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ALTHOUGH THE CUSTOMER REPORTED A FAILING SYSTEM CHECK, THEY REPORTED A SUBSEQUENT SYSTEM CHECK REPEATED THE SAME DAY PASSED WITHIN SPECIFICATIONS; THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION; ADDITIONALLY, THERE WERE NO REPORTS OF SYSTEMIC ISSUES SUCH AS IMPACT TO OTHER ASSAYS IN CONNECTION WITH THIS EVENT. SAMPLE WAS COLLECTED IN BECTON DICKINSON (BD) GEL SERUM. INFORMATION REGARDING TUBE MANUFACTURER, TUBE

  Patient problems: No Code Available

  MAUDE report 10349210 ↗
• InjuryJul 31, 2020Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED LOW SENSITIVE ESTRADIOL (ACCESS SENSITIVE ESTRADIOL) RESULTS WHICH HAD BEEN GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER REPORTED ON 09JULY2020 THAT BASED ON THE QUESTIONED LOW SENSITIVE ESTRADIOL RESULT THERE WAS A DELAY IN PATIENT TREATMENT; SPECIFICALLY, A DELAY IN ADMINISTERING IVF (IN-VITRO FERTILIZATION) THERAPY MEDICATIONS OF FOLLITROPIN ALFA (GONAL-F) AND MENOTROPINS (MENOPUR). THERE WAS NO ADDITIONAL REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTED TESTING ONE SAMPLE DRAWN FROM THE PATIENT TWICE ON ONE DAY. SYSTEM PERFORMANCE INDICATORS SUCH AS QUALITY CONTROL AND CALIBRATIONS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ALTHOUGH THE CUSTOMER REPORTED A FAILING SYSTEM CHECK, THEY REPORTED A SUBSEQUENT SYSTEM CHECK REPEATED THE SAME DAY PASSED WITHIN SPECIFICATIONS; THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION; ADDITIONALLY, THERE WERE NO REPORTS OF SYSTEMIC ISSUES SUCH AS IMPACT TO OTHER ASSAYS IN CONNECTION WITH THIS EVENT. SAMPLE WAS COLLECTED IN BECTON DICKINSON (BD) GEL SERUM TUBE. INFORMATION REGARDING TUBE MANUFACTUR

  Patient problems: No Code Available

  MAUDE report 10349209 ↗
• InjuryJul 31, 2020Low Test Results; Low Test Results

  THE CUSTOMER QUESTIONED LOW SENSITIVE ESTRADIOL (ACCESS SENSITIVE ESTRADIOL) RESULTS WHICH HAD BEEN GENERATED ON THE CUSTOMER'S DXI 800 ACCESS IMMUNOASSAY SYSTEM. THE CUSTOMER REPORTED ON 09JULY2020 THAT BASED ON THE QUESTIONED LOW SENSITIVE ESTRADIOL RESULT THERE WAS A DELAY IN PATIENT TREATMENT; SPECIFICALLY, A DELAY IN ADMINISTERING IVF (IN-VITRO FERTILIZATION) THERAPY MEDICATIONS OF FOLLITROPIN ALFA (GONAL-F) AND MENOTROPINS (MENOPUR). THERE WAS NO ADDITIONAL REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTED TESTING ONE SAMPLE DRAWN FROM THE PATIENT OVER TWO DAYS. SYSTEM PERFORMANCE INDICATORS SUCH AS QUALITY CONTROL AND CALIBRATIONS WERE PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT. ALTHOUGH THE CUSTOMER REPORTED A FAILING SYSTEM CHECK, THEY REPORTED A SUBSEQUENT SYSTEM CHECK REPEATED THE SAME DAY PASSED WITHIN SPECIFICATIONS; THERE IS INSUFFICIENT INFORMATION TO REASONABLY SUGGEST A MALFUNCTION; ADDITIONALLY, THERE WERE NO REPORTS OF SYSTEMIC ISSUES SUCH AS IMPACT TO OTHER ASSAYS IN CONNECTION WITH THIS EVENT. SAMPLE WAS COLLECTED IN BECTON DICKINSON (BD) GEL PLASMA TUBE. INFORMATION REGARDING TUBE MANUFACTURER

  Patient problems: No Code Available

  MAUDE report 10349208 ↗