Access Testosterone 33560Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 15099590231347), received between Jul 11, 2017 and Apr 17, 2024 — classified as 16 injuries.

The most frequently reported specific device problem is “High Test Results” (15 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 5, 2025Open, Classified

   Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result in up to a 34% increase or a 23% decrease in patient results.

   Z-1901-2025 · Root cause: Equipment maintenance · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2024High Test Results; High Test Results

  ON 22MAR2024 THE CUSTOMER REPORTED REPEATABLE ERRONEOUSLY ELEVATED TESTOSTERONE RESULTS (ACCESS TESTOSTERONE, PART NUMBER 33560, LOT NUMBER 338858) WERE GENERATED FOR ONE PATIENT ON THE CUSTOMER'S UNICEL DXI 800 ACCESS IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(6)). THE ELEVATED ACCESS TESTOSTERONE RESULTS WERE DISCORDANT WITH LOW ROCHE AND SIEMENS RESULTS AND WITH THE PATIENT CLINICAL FILE. PER CUSTOMER VERBAL REPORT, THE EXPECTED VALUES WERE CLOSED TO ZERO. THE PATIENT (TRANSGENDER MAN) STOPPED HIS TREATMENT (TESTOGEL) BASED UPON THE ELEVATED ACCESS RESULTS. THE ERRONEOUSLY ELEVATED ACCESS TESTOSTERONE RESULT WAS 2.67 NG/ML ON (B)(6) 2024. PER THE FIELD APPLICATION SPECIALIST (FAS) VERBAL REPORT, THIS RESULT WAS FOUND SIMILAR WHEN REPEATED AT DIFFERENT DAYS AND ON AN ALTERNATE DXI INSTRUMENT (FROM ANOTHER LABORATORY). THE SAMPLE WAS REPEATED WITH THE ROCHE METHODOLOGY WITH A LOWER RESULT (LESS THAN 0.20 NG/ML) ON (B)(6) 2024 AND WITH THE SIEMENS METHODOLOGY WITH A RESULT AT 0 NG/ML. A SECOND SAMPLE FROM THIS PATIENT WAS TESTED. THE PATIENT WAS UNDER TREATMENT WITH TESTOGEL. THE ACCESS TESTOSTERONE RESULT WAS 8 NG/ML AND THE ROCHE TESTOSTERONE RESULT (FROM AN A

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 19124503 ↗
• InjuryAug 11, 2023High Test Results; High Test Results

  ON 20 JULY 2023 THE CUSTOMER REPORTED OBTAINING ERRONEOUS REPEATABLE ELEVATED TESTOSTERONE (ACCESS TESTOSTERONE, PART NUMBER 33560 AND REAGENT LOT NUMBER 338265) ON THEIR ACCESS (ACCESS 2 IMMUNOASSAY ANALYZER, PART NUMBER 81600N AND SERIAL NUMBER (B)(6)) FOR ONE PATIENT BEGINNING IN (B)(6) 2023. THE ELEVATED TESTOSTERONE RESULTS WERE RELEASED FROM THE LABORATORY. THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED THE PATIENT RECEIVED AN INJECTION OF FIRMAGON ON (B)(6) 2023 (DOSE ADMINISTERED NOT PROVIDED). THERE WAS NO FURTHER REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT IN CONNECTION WITH THIS EVENT. CUSTOMER STATED ANOTHER SAMPLE WAS COLLECTED AND SENT TO A REFERENCE LAB (B)(6); LOWER RESULTS WERE OBTAINED. CUSTOMER DID NOT KNOW REFERENCE LAB TESTING METHODOLOGY. CUSTOMER ALSO REPORTED SENDING A SAMPLE TO ANOTHER LABORATORY, (B)(6) LABORATORY AND REPORTED RESULTS OF TESTING PERFORMED AT (B)(6) LABORATORY MATCHED THE RESULTS OBTAINED AT QUEST. CUSTOMER REPORTED THE (B)(6) LABORATORY USED A ROCHE PLATFORM. NO HARDWARE ERRORS OR ISSUES WITH OTHER ASSAYS WERE REPORTED IN CONJUNCTION WITH THIS EVENT. NO OTHER PAT

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17509906 ↗
• InjuryDec 22, 2020High Test Results; High Test Results

  ON (B)(6) 2020, THE CUSTOMER REPORTED OBTAINING A FALSE HIGH TESTOSTERONE RESULT (ACCESS TESTOSTERONE PART NUMBER 33560 AND LOT NUMBER 921781) FOR ONE PATIENT INVOLVING THE LABORATORY'S UNICEL DXI 800 IMMUNOASSAY ANALYZER (PART NUMBER 973100 AND SERIAL NUMBER (B)(4)). THE INITIAL FALSE HIGH ACCESS TESTOSTERONE RESULT OF 235.26 NG/DL WAS OBTAINED ON (B)(6) 2020. THE RESULT WAS OBTAINED WITH CEX (CALIBRATION EXPIRED) AND CLX (CALIBRATOR LOT EXPIRED) FLAGS. UPON REPEAT ON (B)(6) 2020 ON SAME ANALYZER WITH A NEW REAGENT PACK AND NEW CALIBRATION, THE RESULT WAS 21.76 NG/DL WHICH WAS ACCORDANT WITH THE CUSTOMER EXPECTATION. THE PATIENT WHO HAS AN ADVANCED PROSTATE CANCER WAS ADMINISTERED MEDICINE (NAME NOT PROVIDED BY CUSTOMER) TO DECREASE THE TESTOSTERONE RATE BASED ON THE ERRONEOUS ELEVATED ACCESS TESTOSTERONE RESULT. THERE WAS NO ADDITIONAL CHANGE TO OR IMPACT TO PATIENT CARE REPORTED IN ASSOCIATION WITH THIS INCIDENT. SYSTEM CHECK PASSED ON 10NOV2020. PER CUSTOMER¿S VERBAL REPORT, QC WAS OUT HIGH AND UNACCEPTABLE AT THE TIME OF THE EVENT. NO HARDWARE ERRORS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS EVENT. SAMPLE INFORMATION SUCH AS SAMPLE COLLECTION TUBE USED, CENT

  Patient problems: Insufficient Information

  MAUDE report 11054740 ↗
• InjuryMay 1, 2020High Test Results; High Test Results

  ON (B)(6) 2020, THE CUSTOMER REPORTED OBTAINING ELEVATED TESTOSTERONE (ACCESS TESTOSTERONE) RESULTS FOR EIGHT FEMALE PATIENTS INVOLVING THE LABORATORY'S UNICEL DXI 800 IMMUNOASSAY SYSTEM (PART NUMBER 973100 AND SERIAL NUMBER (SN) (B)(4)). THE CUSTOMER DID NOT PROVIDE A REFERENCE RANGE; THE BECKMAN COULTER TESTOSTERONE REFERENCE RANGE FOR FEMALES IS: SERUM: <0.1 ¿ 0.75 NG/ML (<0.1 ¿ 2.60 NMOL/L). PLASMA: <0.1 ¿ 0.90 NG/ML (<0.1 ¿ 3.12 NMOL/L). THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE EIGHT PATIENTS WERE PRESCRIBED MEDICATION TO REDUCE TESTOSTERONE LEVELS (MEDICATION NAME, DOSAGE AND DATES NOT PROVIDED) DUE TO THE ELEVATED TESTOSTERONE RESULTS. NO FURTHER INFORMATION WAS PROVIDED REGARDING CHANGE TO OR IMPACT TO PATIENT CARE WAS REPORTED IN CONNECTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK WAS PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT; IT WAS NOTED THAT THE CALIBRATION, WHICH WAS PERFORMED ON (B)(6) 2019 WAS EXPIRED AT THE TIME OF THE EVENT (CALIBRATION EXPIRED ON 15NOV2019). QUALITY CONTROL TESTING RESULTS WERE REPORTED TO BE HIGH AND UNACCEPTABLE. CUSTOMER¿S QUALITY CO

  Patient problems: No Code Available

  MAUDE report 10017535 ↗
• InjuryMay 1, 2020High Test Results; High Test Results

  ON (B)(6) 2020, THE CUSTOMER REPORTED OBTAINING ELEVATED TESTOSTERONE (ACCESS TESTOSTERONE) RESULTS FOR EIGHT FEMALE PATIENTS INVOLVING THE LABORATORY'S UNICEL DXI 800 IMMUNOASSAY SYSTEM (PART NUMBER 973100 AND SERIAL NUMBER (SN) (B)(4)). THE CUSTOMER DID NOT PROVIDE A REFERENCE RANGE; THE BECKMAN COULTER TESTOSTERONE REFERENCE RANGE FOR FEMALES IS: SERUM: <0.1 ¿ 0.75 NG/ML (<0.1 ¿ 2.60 NMOL/L). PLASMA: <0.1 ¿ 0.90 NG/ML (<0.1 ¿ 3.12 NMOL/L). THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE EIGHT PATIENTS WERE PRESCRIBED MEDICATION TO REDUCE TESTOSTERONE LEVELS (MEDICATION NAME, DOSAGE AND DATES NOT PROVIDED) DUE TO THE ELEVATED TESTOSTERONE RESULTS. NO FURTHER INFORMATION WAS PROVIDED REGARDING CHANGE TO OR IMPACT TO PATIENT CARE WAS REPORTED IN CONNECTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK WAS PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT; IT WAS NOTED THAT THE CALIBRATION, WHICH WAS PERFORMED ON (B)(6) 2019 WAS EXPIRED AT THE TIME OF THE EVENT (CALIBRATION EXPIRED ON 15NOV2019). QUALITY CONTROL TESTING RESULTS WERE REPORTED TO BE HIGH AND UNACCEPTABLE. CUSTOMER¿S QUALITY CO

  Patient problems: No Code Available

  MAUDE report 10017533 ↗
• InjuryMay 1, 2020High Test Results; High Test Results

  ON (B)(6) 2020, THE CUSTOMER REPORTED OBTAINING ELEVATED TESTOSTERONE (ACCESS TESTOSTERONE) RESULTS FOR EIGHT FEMALE PATIENTS INVOLVING THE LABORATORY'S UNICEL DXI 800 IMMUNOASSAY SYSTEM (PART NUMBER 973100 AND SERIAL NUMBER (SN) (B)(4)). THE CUSTOMER DID NOT PROVIDE A REFERENCE RANGE; THE BECKMAN COULTER TESTOSTERONE REFERENCE RANGE FOR FEMALES IS: SERUM: <0.1 ¿ 0.75 NG/ML (<0.1 ¿ 2.60 NMOL/L). PLASMA: <0.1 ¿ 0.90 NG/ML (<0.1 ¿ 3.12 NMOL/L). THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE EIGHT PATIENTS WERE PRESCRIBED MEDICATION TO REDUCE TESTOSTERONE LEVELS (MEDICATION NAME, DOSAGE AND DATES NOT PROVIDED) DUE TO THE ELEVATED TESTOSTERONE RESULTS. NO FURTHER INFORMATION WAS PROVIDED REGARDING CHANGE TO OR IMPACT TO PATIENT CARE WAS REPORTED IN CONNECTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK WAS PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT; IT WAS NOTED THAT THE CALIBRATION, WHICH WAS PERFORMED ON (B)(6) 2019 WAS EXPIRED AT THE TIME OF THE EVENT (CALIBRATION EXPIRED ON 15NOV2019). QUALITY CONTROL TESTING RESULTS WERE REPORTED TO BE HIGH AND UNACCEPTABLE. CUSTOMER¿S QUALITY CO

  Patient problems: No Code Available

  MAUDE report 10017532 ↗
• InjuryMay 1, 2020High Test Results; High Test Results

  ON (B)(6) 2020, THE CUSTOMER REPORTED OBTAINING ELEVATED TESTOSTERONE (ACCESS TESTOSTERONE) RESULTS FOR EIGHT FEMALE PATIENTS INVOLVING THE LABORATORY'S UNICEL DXI 800 IMMUNOASSAY SYSTEM (PART NUMBER 973100 AND SERIAL NUMBER (SN) (B)(4)). THE CUSTOMER DID NOT PROVIDE A REFERENCE RANGE; THE BECKMAN COULTER TESTOSTERONE REFERENCE RANGE FOR FEMALES IS: SERUM: <0.1 ¿ 0.75 NG/ML (<0.1 ¿ 2.60 NMOL/L). PLASMA: <0.1 ¿ 0.90 NG/ML (<0.1 ¿ 3.12 NMOL/L). THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE EIGHT PATIENTS WERE PRESCRIBED MEDICATION TO REDUCE TESTOSTERONE LEVELS (MEDICATION NAME, DOSAGE AND DATES NOT PROVIDED) DUE TO THE ELEVATED TESTOSTERONE RESULTS. NO FURTHER INFORMATION WAS PROVIDED REGARDING CHANGE TO OR IMPACT TO PATIENT CARE WAS REPORTED IN CONNECTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK WAS PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT; IT WAS NOTED THAT THE CALIBRATION, WHICH WAS PERFORMED ON (B)(6) 2019 WAS EXPIRED AT THE TIME OF THE EVENT (CALIBRATION EXPIRED ON 15NOV2019). QUALITY CONTROL TESTING RESULTS WERE REPORTED TO BE HIGH AND UNACCEPTABLE. CUSTOMER¿S QUALITY CO

  Patient problems: No Code Available

  MAUDE report 10017527 ↗
• InjuryMay 1, 2020High Test Results; High Test Results

  ON (B)(6) 2020, THE CUSTOMER REPORTED OBTAINING ELEVATED TESTOSTERONE (ACCESS TESTOSTERONE) RESULTS FOR EIGHT FEMALE PATIENTS INVOLVING THE LABORATORY'S UNICEL DXI 800 IMMUNOASSAY SYSTEM (PART NUMBER 973100 AND SERIAL NUMBER (SN) (B)(4)). THE CUSTOMER DID NOT PROVIDE A REFERENCE RANGE; THE BECKMAN COULTER TESTOSTERONE REFERENCE RANGE FOR FEMALES IS: SERUM: <0.1 ¿ 0.75 NG/ML (<0.1 ¿ 2.60 NMOL/L). PLASMA: <0.1 ¿ 0.90 NG/ML (<0.1 ¿ 3.12 NMOL/L). THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE EIGHT PATIENTS WERE PRESCRIBED MEDICATION TO REDUCE TESTOSTERONE LEVELS (MEDICATION NAME, DOSAGE AND DATES NOT PROVIDED) DUE TO THE ELEVATED TESTOSTERONE RESULTS. NO FURTHER INFORMATION WAS PROVIDED REGARDING CHANGE TO OR IMPACT TO PATIENT CARE WAS REPORTED IN CONNECTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK WAS PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT; IT WAS NOTED THAT THE CALIBRATION, WHICH WAS PERFORMED ON (B)(6) 2019 WAS EXPIRED AT THE TIME OF THE EVENT (CALIBRATION EXPIRED ON 15NOV2019). QUALITY CONTROL TESTING RESULTS WERE REPORTED TO BE HIGH AND UNACCEPTABLE. CUSTOMER¿S QUALITY CO

  Patient problems: No Code Available

  MAUDE report 10017526 ↗
• InjuryMay 1, 2020High Test Results; High Test Results

  ON (B)(6) 2020, THE CUSTOMER REPORTED OBTAINING ELEVATED TESTOSTERONE (ACCESS TESTOSTERONE) RESULTS FOR EIGHT FEMALE PATIENTS INVOLVING THE LABORATORY'S UNICEL DXI 800 IMMUNOASSAY SYSTEM (PART NUMBER 973100 AND SERIAL NUMBER (SN) (B)(4)). THE CUSTOMER DID NOT PROVIDE A REFERENCE RANGE; THE BECKMAN COULTER TESTOSTERONE REFERENCE RANGE FOR FEMALES IS: SERUM: <0.1 ¿ 0.75 NG/ML (<0.1 ¿ 2.60 NMOL/L). PLASMA: <0.1 ¿ 0.90 NG/ML (<0.1 ¿ 3.12 NMOL/L). THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE EIGHT PATIENTS WERE PRESCRIBED MEDICATION TO REDUCE TESTOSTERONE LEVELS (MEDICATION NAME, DOSAGE AND DATES NOT PROVIDED) DUE TO THE ELEVATED TESTOSTERONE RESULTS. NO FURTHER INFORMATION WAS PROVIDED REGARDING CHANGE TO OR IMPACT TO PATIENT CARE WAS REPORTED IN CONNECTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK WAS PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT; IT WAS NOTED THAT THE CALIBRATION, WHICH WAS PERFORMED ON (B)(6) 2019 WAS EXPIRED AT THE TIME OF THE EVENT (CALIBRATION EXPIRED ON 15NOV2019). QUALITY CONTROL TESTING RESULTS WERE REPORTED TO BE HIGH AND UNACCEPTABLE. CUSTOMER¿S QUALITY CO

  Patient problems: No Code Available

  MAUDE report 10017524 ↗
• InjuryMay 1, 2020High Test Results; High Test Results

  ON (B)(6) 2020, THE CUSTOMER REPORTED OBTAINING ELEVATED TESTOSTERONE (ACCESS TESTOSTERONE) RESULTS FOR EIGHT FEMALE PATIENTS INVOLVING THE LABORATORY'S UNICEL DXI 800 IMMUNOASSAY SYSTEM (PART NUMBER 973100 AND SERIAL NUMBER (SN) (B)(4)). THE CUSTOMER DID NOT PROVIDE A REFERENCE RANGE; THE BECKMAN COULTER TESTOSTERONE REFERENCE RANGE FOR FEMALES IS: SERUM: <0.1 ¿ 0.75 NG/ML (<0.1 ¿ 2.60 NMOL/L). PLASMA: <0.1 ¿ 0.90 NG/ML (<0.1 ¿ 3.12 NMOL/L). THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE EIGHT PATIENTS WERE PRESCRIBED MEDICATION TO REDUCE TESTOSTERONE LEVELS (MEDICATION NAME, DOSAGE AND DATES NOT PROVIDED) DUE TO THE ELEVATED TESTOSTERONE RESULTS. NO FURTHER INFORMATION WAS PROVIDED REGARDING CHANGE TO OR IMPACT TO PATIENT CARE WAS REPORTED IN CONNECTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK WAS PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT; IT WAS NOTED THAT THE CALIBRATION, WHICH WAS PERFORMED ON (B)(6) 2019 WAS EXPIRED AT THE TIME OF THE EVENT (CALIBRATION EXPIRED ON 15NOV2019). QUALITY CONTROL TESTING RESULTS WERE REPORTED TO BE HIGH AND UNACCEPTABLE. CUSTOMER¿S QUALITY CO

  Patient problems: No Code Available

  MAUDE report 10017522 ↗
• InjuryMay 1, 2020High Test Results; High Test Results

  ON (B)(6) 2020, THE CUSTOMER REPORTED OBTAINING ELEVATED TESTOSTERONE (ACCESS TESTOSTERONE) RESULTS FOR EIGHT FEMALE PATIENTS INVOLVING THE LABORATORY'S UNICEL DXI 800 IMMUNOASSAY SYSTEM (PART NUMBER 973100 AND SERIAL NUMBER (SN) (B)(4)). THE CUSTOMER DID NOT PROVIDE A REFERENCE RANGE; THE BECKMAN COULTER TESTOSTERONE REFERENCE RANGE FOR FEMALES IS: SERUM: <0.1 ¿ 0.75 NG/ML (<0.1 ¿ 2.60 NMOL/L). PLASMA: <0.1 ¿ 0.90 NG/ML (<0.1 ¿ 3.12 NMOL/L). THERE WAS A REPORT OF CHANGE TO PATIENT TREATMENT OR MANAGEMENT WHICH OCCURRED IN CONNECTION WITH THIS EVENT. THE EIGHT PATIENTS WERE PRESCRIBED MEDICATION TO REDUCE TESTOSTERONE LEVELS (MEDICATION NAME, DOSAGE AND DATES NOT PROVIDED) DUE TO THE ELEVATED TESTOSTERONE RESULTS. NO FURTHER INFORMATION WAS PROVIDED REGARDING CHANGE TO OR IMPACT TO PATIENT CARE WAS REPORTED IN CONNECTION WITH THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS SYSTEM CHECK WAS PASSING WITHIN SPECIFICATIONS AT THE TIME OF THE EVENT; IT WAS NOTED THAT THE CALIBRATION, WHICH WAS PERFORMED ON (B)(6) 2019 WAS EXPIRED AT THE TIME OF THE EVENT (CALIBRATION EXPIRED ON 15NOV2019). QUALITY CONTROL TESTING RESULTS WERE REPORTED TO BE HIGH AND UNACCEPTABLE. CUSTOMER¿S QUALITY CO

  Patient problems: No Code Available

  MAUDE report 10017520 ↗
• InjuryDec 11, 2019High Test Results; High Test Results

  THE CUSTOMER CONTACTED BECKMAN COULTER (BCI) ON (B)(6) 2019 TO REPORT OBTAINING AN ELEVATED TESTOSTERONE (ACCESS TESTOSTERONE) RESULT FOR ONE (1) PATIENT ON THE LABORATORY'S ACCESS 2 IMMUNOASSAY ANALYZER, SERIAL NUMBER (B)(4). THE PATIENT'S SAMPLE WAS COLLECTED ON (B)(6) 2019 AND TESTED ON (B)(6) 2019. THE INITIAL ACCESS TESTOSTERONE RESULT WAS SIGNIFICANTLY ELEVATED. THE SAME SAMPLE WAS REANALYZED ON THE SAME ACCESS 2 IMMUNOASSAY ANALYZER AND A LOWER RESULT WAS OBTAINED. THE CUSTOMER NOTED THAT ON (B)(6) 2019 THE PATIENT WAS REDRAWN AND TESTED AGAIN ON THE ACCESS TESTOSTERONE ASSAY WHICH SUBSEQUENTLY PRODUCED A RESULT THAT MATCHED THE LOWER OF THE TWO (2) RESULTS OBTAINED FROM THE ORIGINAL SAMPLE. THE CUSTOMER STATED THAT THERE WAS A CHANGE TO PATIENT TREATMENT/MANAGEMENT AS THIS PARTICULAR PATIENT'S HORMONE REPLACEMENT THERAPY WAS CANCELLED DUE TO THE INITIAL, ELEVATED ACCESS TESTOSTERONE RESULT OBTAINED. THERE WAS NO REPORT OF AN INJURY OR DEATH ATTRIBUTABLE TO THIS EVENT. SYSTEM PERFORMANCE INDICATORS SUCH AS QUALITY CONTROLS (QC), CALIBRATIONS, PRECISION TESTING AND SYSTEM CHECKS WERE PASSING WITHIN INSTRUMENT AND ASSAY SPECIFICATIONS AFTER THE EVENT. THERE WAS NO REPORT OF HA

  Patient problems: No Code Available

  MAUDE report 9453132 ↗
• InjuryApr 22, 2019High Test Results; High Test Results

  ON (B)(6) 2019 THE CUSTOMER REPORTED THAT ON (B)(6) 2019 AN ELEVATED TESTOSTERONE (ACCESS TESTOSTERONE, TOTAL) RESULT HAD BEEN GENERATED ON THE CUSTOMER'S ACCESS 2 ANALYZER (SERIAL NUMBER (B)(4)) FOR ONE PATIENT SAMPLE. THE INITIAL ELEVATED ACCESS TESTOSTERONE, TOTAL RESULT OF >0.75 MG/ML WAS RELEASED FROM THE LABORATORY. THE CUSTOMER REPORTED ADMINISTERING MEDICATION TO THE PATIENT IN ORDER TO DECREASE THE TESTOSTERONE LEVEL; HOWEVER, THE DETAILS OF WHAT MEDICATION WAS ADMINISTERED WAS NOT PROVIDED. THERE WAS NO ADDITIONAL CHANGE TO OR IMPACT TO PATIENT CARE REPORTED IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER REPORTED RETESTING THE SAMPLE ON A COMPETITOR DEVICE AND OBTAINED A LOWER RESULT. THE CUSTOMER DID NOT PROVIDE THE RESULTS OR A REFERENCE RANGE FOR THE COMPETITOR DEVICE. CALIBRATION WAS PASSING AT THE TIME OF THE EVENT. SYSTEM CHECK WAS PERFORMED ON (B)(6) 2019 AND PASSED WITHIN SPECIFICATIONS. NO SAMPLE COLLECTION INFORMATION SUCH AS SAMPLE TYPE, SAMPLE TUBE TYPE OR SIZE, CENTRIFUGATION TIME OR SPEED OR ANY OTHER SAMPLE PROCESSING INFORMATION WAS PROVIDED.

  Patient problems: No Code Available

  MAUDE report 8535856 ↗
• InjuryDec 11, 2018High Test Results; High Test Results

  THE CUSTOMER REPORTED OBTAINING REPRODUCIBLE HIGH TESTOSTERONE RESULTS FOR ONE (1) PATIENT INVOLVING THE LABORATORY'S UNICEL DXI 800 IMMUNOASSAY SYSTEMS (SERIAL NUMBER (B)(4)). FOUR (4) DIFFERENT SAMPLES FROM THIS SAME PATIENT GAVE HIGH TESTOSTERONE RESULTS BETWEEN (B)(6) 2017 AND (B)(6) 2018. THE PATIENT UNDERWENT SURGICAL REMOVAL OF THE OVARIES IN (B)(6) 2018 BECAUSE OF THE ELEVATED TESTOSTERONE RESULTS AS WELL AS THE PATIENT CLINICAL PICTURE. THE PATIENT PRESENTED HIRSUTISM ON THE FACE, BIGGER THAN EXPECTED OVARIES AND HAIR LOSS. THE PATIENT IS A (B)(6)-YEAR-OLD POSTMENOPAUSAL FEMALE. NO OTHER CHANGE TO TREATMENT HAS BEEN REPORTED BY THE CUSTOMER. RESULTS POST-SURGERY WERE DISCORDANT TO THE PATIENT CLINICAL FILE. TESTING ON THE SIEMENS ADVIA CENTAUR RECOVERED WITHIN THE EXPECTED RANGE. NO HARDWARE ERRORS, FLAGS OR OTHER ASSAY ISSUES WERE REPORTED IN CONJUNCTION WITH THIS INCIDENT.

  Patient problems: No Code Available

  MAUDE report 8151351 ↗
• InjuryNov 29, 2018Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE ESTRADIOL, TSH, FREE T3, AND TESTOSTERONE PATIENT RESULTS INVOLVING THE LABORATORY'S ACCESS 2 IMMUNOASSAY ANALYZER (SERIAL NUMBER (B)(4)). THERE WAS A CHANGE TO TREATMENT FOR ONE PATIENT BASED ON A TESTOSTERONE RESULT. THE PATIENT HAD A CHANGE IN INJECTION AMOUNT. THERE WAS NO REPORTED INJURY OR ILLNESS TO THE PATIENT IN THIS EVENT. QUALITY CONTROL (QC) RECOVERED OUTSIDE CUSTOMER¿S ESTABLISHED RANGES FOR MULTIPLE ASSAYS. THE CUSTOMER RECALIBRATED AND/OR USED FRESH QC AND RECOVERED WITHIN RANGE. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER FOR THIS INITIAL SAMPLE.

  Patient problems: No Code Available

  MAUDE report 8114858 ↗
• InjuryJul 11, 2017High Test Results; High Test Results

  THE CUSTOMER REPORTED OBTAINING REPRODUCIBLY ELEVATED TESTOSTERONE, TOTAL (ACCESS TESTOSTERONE) RESULTS ON THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM SERIAL NUMBER (B)(4) AND AN ALTERNATE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM (SERIAL NUMBER NOT SPECIFIED) FOR ONE (1) PATIENT. THE PATIENT WAS PRESCRIBED ETHINYLESTRADIOL AND CYPROTERONE ACETATE TABLETS DUE TO THE HIGH ACCESS TESTOSTERONE RESULTS. THE SAMPLE WAS ALSO TESTED ON A SIEMENS ANALYZER AND A LOWER RESULT WAS OBTAINED. QUALITY CONTROL WAS RECOVERING WITHIN ASSAY/INSTRUMENT SPECIFICATIONS. CALIBRATIONS AND SYSTEM INFORMATION WERE NOT PROVIDED. THE PATIENT SAMPLE WAS SERUM. NO CENTRIFUGATION INFORMATION WAS PROVIDED. NO ISSUES WITH SAMPLE INTEGRITY WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Code Available

  MAUDE report 6700223 ↗