Elecsys PTH 07251068190Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04015630939787), received between Jul 7, 2021 and Nov 24, 2025 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (13 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 24, 2025Low Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS PTH ON A COBAS E 801 ANALYTICAL UNIT AND A COBAS E 602 MODULE. OVER A LONG PERIOD OF MONITORING, THE PATIENT HAS HAD A PTH CONCENTRATION IN THE NORMAL REFERENCE RANGE OF 15 - 65 PG/ML. THE SAMPLE RESULTED IN PTH VALUES OF 25.1 PG/ML, 24.4 PG/ML, 25.9 PG/ML, AND 19.9 PG/ML WHEN TESTED ON THE E 801 ANALYZER. THE SAMPLE WAS TREATED WITH A 25% POLYETHYLENE GLYCOL (PEG) SOLUTION IN A 1:1 RATIO, RESULTING IN PTH VALUES OF 40.2 PG/ML (160.16 % RECOVERY) AND 51.8 PG/ML ON THE E 801 ANALYZER. THE SAMPLE WAS DILUTED 1:2 AND TESTED ON THE E801 SYSTEM, RESULTING IN A RAW PTH VALUE OF 9.34 PG/ML WHICH CALCULATED TO A FINAL VALUE OF 18.68 PG/ML WHEN ACCOUNTING FOR THE DILUTION FACTOR. THE SAMPLE WAS DILUTED 1:4 AND TESTED ON THE E801 SYSTEM, RESULTING IN A RAW PTH VALUE OF 5.85 PG/ML WHICH CALCULATED TO A FINAL VALUE OF 23.4 PG/ML WHEN ACCOUNTING FOR THE DILUTION FACTOR. THE SAMPLE WAS DILUTED 1:8 AND TESTED ON THE E801 SYSTEM, RESULTING IN A RAW PTH VALUE OF 5.68 PG/ML WHICH CALCULATED TO A FINAL VALUE OF 45.44 PG/ML WHEN ACCOUNTING FOR THE DILUTION FACTOR. THE SAMPLE WAS DILUTED 1:16 AND TES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23632039 ↗
• MalfunctionOct 15, 2025Output Problem; Non Reproducible Results; Output Problem; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS PTH ON TWO COBAS E 801 ANALYTICAL UNIT ANALYZERS. THE SAMPLE INITIALLY RESULTED IN A PTH VALUE OF 65.3 PG/ML WHEN TESTED ON THE FIRST E 801 ANALYZER. THE DOCTOR QUESTIONED THE RESULT, SO THE SAMPLE WAS REPEATED. WHEN REPEATED ON A SECOND E 801 ANALYZER, THE RESULT WAS 84.9 PG/ML. WHEN REPEATED ON A THIRD E 801 ANALYZER, THE RESULT WAS 61.0 PG/ML. THE CUSTOMER DEEMED THE PTH VALUE OF 84.9 PG/ML TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294953 ↗
• MalfunctionAug 27, 2025High Test Results; High Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS PTH RESULTS FROM ONE PATIENT SAMPLE TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT FROM THE ANALYZER WAS 451 PG/ML. THIS RESULT WAS DEEMED ELEVATED. THE REPEAT RESULT FROM A BECKMAN I800 PLATFORM WAS 2.5 PMOL/L. THIS RESULT WAS WITHIN THE NORMAL RANGE. THE REPORTER PERFORMED A SERIAL DILUTION: THE REPEAT RESULT AT 2X DILUTION WAS 452 PG/ML. THE REPEAT RESULT AT 4X DILUTION WAS 476 PG/ML. THE REPEAT RESULT AT 8X DILUTION WAS 517.6 PG/ML. THE REPEAT RESULT AT 16X DILUTION WAS 553.6 PG/ML. THE REPEAT RESULT AT 32X DILUTION WAS 601.6 PG/ML THE REPORTER NOTED THAT THE SERIAL DILUTION RESULTS HAD NO DILUTION LINEARITY. THE REPORTER SUSPECTS A SAMPLE-SPECIFIC INTERFERENT IN THE PATIENT SAMPLE BASED ON THE CLINICAL AND LABORATORY FINDINGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22902393 ↗
• MalfunctionJun 6, 2025Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS PARATHYROID HORMONE (PTH) ASSAY ON A COBAS PRO SSU ANALYZER. INITIAL RESULT: 455 PG/ML (TESTED ON THE CUSTOMER'S E801 ANALYZER). TWO OTHER TUBES WERE DRAWN FROM THE PATIENT AT THE SAME TIME: TUBE 2 AND TUBE 3. THE CUSTOMER PROVIDED TUBE 2 AND TUBE 3 FOR INVESTIGATION, WHERE THEY WERE TESTED ON 13-MAY-2025 ON A 2ND E801 ANALYZER: TUBE 2 RESULTS WERE 332 PG/ML AND 325 PG/ML. TUBE 3 RESULT WAS 321 PG/ML. ON 14-MAY-2025, TUBE 2 WAS ALSO REPEATED ON E801 AT THE INVESTIGATION SITE, AND THE REPEAT RESULT WAS 319 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22160779 ↗
• InjuryMay 16, 2025Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER ALLEGED THAT THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS PTH ON A COBAS E 801 ANALYTICAL UNIT. THE PATIENT'S SURGERY WAS ALLEGEDLY STOPPED DUE TO A REPORTED INCORRECT PTH VALUE. A FIRST SAMPLE COLLECTED FROM THE PATIENT REPORTEDLY RESULTED IN A PTH VALUE OF 118 PG/ML. DURING THE SURGERY, A SECOND SAMPLE COLLECTED FROM THE PATIENT WAS LOADED INTO A SAMPLE CUP AND TESTED, REPORTEDLY RESULTING IN A PTH VALUE OF 5.94 PG/ML. THE PATIENT'S SURGERY WAS ALLEGEDLY STOPPED DUE TO THIS VALUE. THE SECOND SAMPLE WAS THEN REPEATED, REPORTEDLY RESULTING IN A PTH VALUE OF 125 PG/ML. IT WAS REPORTED THAT THIS REPEAT VALUE WAS REPORTED TO THE PHYSICIAN. A THIRD SAMPLE WAS COLLECTED FROM THE PATIENT ON (B)(6) 2025 AND TESTED TWICE, REPORTEDLY RESULTING IN PTH VALUES OF 112 PG/ML AND 99.9 PG/ML. THE PATIENT ALLEGEDLY HAD A SECOND SURGERY PERFORMED ON (B)(6) 2025 AND THE SITUATION IS REPORTED TO BE STABILIZED. SAMPLES COLLECTED DURING THIS SURGERY WERE ALLEGEDLY SENT TO AN EXTERNAL LABORATORY FOR TESTING. THE CUSTOMER ALLEGED THAT THERE WERE DIFFERENCES BETWEEN RESULTS OF THE SAME SAMPLES SENT TO THE EXTERNAL LABORATORY AND THE RESULTS OBTAINED WITH

  Patient problems: Insufficient Information

  MAUDE report 22035167 ↗
• MalfunctionSep 19, 2024Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PTH RESULTS FROM THE COBAS E 801 ANALYTICAL UNIT. SAMPLE 1 INITIAL RESULT WAS 1.06 PMOL/L. THE REPEAT RESULT ON THE SAME ANALYZER WAS 17.2 PMOL/L. THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 17.2 PMOL/L. SAMPLE 2 INITIAL RESULT WAS 1.17 PMOL/L. THE REPEAT RESULT ON THE SAME ANALYZER WAS 17.2 PMOL/L. THE REPEAT RESULT FROM ANOTHER ANALYZER WAS 17.2 PMOL/L. ADDITIONAL RESULTS OF 8.86 PMOL/L AND 9.16 PMOL/L WERE PROVIDED FOR THIS SAMPLE. CLARIFICATION WAS REQUESTED BUT NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20261727 ↗
• MalfunctionNov 17, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS PTH ON A COBAS E 801 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A PTH VALUE OF 6.56 PG/ML. THE DOCTOR QUESTIONED THE RESULT AS THE PATIENT HAD A PREVIOUS PTH VALUE OF 199 NG/ML. THE SAMPLE WAS REPEATED, RESULTING IN A VALUE OF 267 PG/ML.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18162954 ↗
• MalfunctionNov 9, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ELECSYS PTH ON TWO COBAS E 801 MODULE ANALYZERS. REFER TO THE ATTACHMENT FOR ALL PATIENT DATA. THE SAMPLE WAS INITIALLY TESTED ON THE CUSTOMER'S E 801 ANALYZER ON (B)(6) 2023. THE CUSTOMER REPEATED THE SAMPLE WITH X2, X4, AND X8 DILUTIONS. THE PATIENT'S PREVIOUS PTH VALUES RANGED BETWEEN 50 AND 100 PG/ML, SO THE RESULTS FROM THE COMPLAINED SAMPLE WERE QUESTIONED. THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED WITH PTH AND PTH (1-84) ON A SECOND E 801 ANALYZER ON (B)(6) 2023. PTH AND PTH (1-84) WERE ALSO RE-MEASURED AFTER X2, X4, AND X8 MANUAL DILUTIONS WITH BOTH LOW PTH PATIENT SERUM AND DILUENT SOLUTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107005 ↗
• MalfunctionAug 1, 2023Low Test Results; Non Reproducible Results; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FOUR PATIENT SAMPLES TESTED WITH ELECSYS PTH ON A COBAS E 801 ANALYTICAL UNIT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE INITIALLY RESULTED IN A PTH VALUE OF 7.05 PG/ML AND IT REPEATED AS 39.4 PG/ML. THE SECOND SAMPLE INITIALLY RESULTED IN A PTH VALUE OF 7.17 PG/ML AND IT REPEATED AS 26.6 PG/ML. THE THIRD SAMPLE INITIALLY RESULTED IN A PTH VALUE OF 7.42 PG/ML AND IT REPEATED AS 192 PG/ML. THE FOURTH SAMPLE INITIALLY RESULTED IN A PTH VALUE OF 7.16 PG/ML AND IT REPEATED AS 32.2 PG/ML. THE REPEAT VALUES WERE MORE IN LINE WITH THE PREVIOUS RESULTS OF THE PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435967 ↗
• MalfunctionJul 17, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR SAMPLES FROM ONE PATIENT TESTED WITH THE ELECSYS PTH ASSAY AND COMPARED TO A COMPETITOR METHOD. THE ELECSYS PTH RESULTS DID NOT AGREE WITH THE PATIENT¿S CLINICAL PICTURE AND THE CUSTOMER SUSPECTS AN INTERFERENCE IN THE PATIENT SAMPLE AFFECTING THE ELECSYS PTH RESULTS. ON (B)(6) 2023, A SAMPLE FROM THE PATIENT HAD AN ELECSYS PTH VALUE OF 2657.0 PG/ML. ON (B)(6) 2023, A SAMPLE FROM THE PATIENT HAD AN ELECSYS PTH VALUE OF 2849.0 PG/ML. AT AN UNKNOWN DATE, A SAMPLE FROM THE PATIENT HAD A PTH COMPETITOR VALUE OF 53.2 NG/L (REFERENCE RANGE 18.4-80.1 NG/ML). IT WAS ASKED BUT IT IS UNKNOWN WHICH SAMPLE WAS USED FOR THIS MEASUREMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17337644 ↗
• MalfunctionJun 15, 2023Low Test Results; Low Test Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS PTH (PTH) ON A COBAS E 801 MODULE COMPARED TO THE ABBOTT METHOD. ON (B)(6) 2023 THE INITIAL RESULT WAS 1.20 PG/ML. THE CUSTOMER REPEATED THE SAMPLE ON 2 DIFFERENT INSTRUMENTS IN THE LABORATORY AND RECEIVED THE SAME RESULT. ON (B)(6) 2023 THE CUSTOMER SENT THE SAMPLE TO ANOTHER LABORATORY WHERE THE RESULT FROM THE ABBOTT METHOD WAS 20.2 PG/ML. IT IS NOT KNOWN IF THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER SUSPECTS AN INTERFERENCE IN THE SAMPLE. THE E801 MODULE SERIAL NUMBER WAS(B)(6) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17138143 ↗
• MalfunctionMay 29, 2023Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS PTH ASSAY ON A COBAS E 801 MODULE, SERIAL NUMBER (B)(6) . THE SAMPLE INITIALLY RESULTED IN A PTH VALUE OF 84.4 PG/ML. THE SAMPLE WAS REPEATED TWO TIMES, RESULTING IN PTH VALUES OF 70.5 PG/ML AND 69.0 PG/ML. ON (B)(6) 2023, THE SAMPLE WAS CENTRIFUGED AND SENT TO ANOTHER LABORATORY USING AN E801 MODULE. THE REPEAT RESULT FROM A SECONDARY TUBE WAS 20.8 PG/ML. IT WAS ASKED BUT IT IS UNKNOWN IF A QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016416 ↗
• MalfunctionMay 12, 2023High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS PTH ASSAY ON A COBAS E 801 MODULE, SERIAL NUMBER (B)(6), AND COMPARED TO A COMPETITOR METHOD. THE SAMPLE WAS COLLECTED ON (B)(6) 2023 AND INITIALLY RESULTED IN A PTH VALUE OF 405 PG/ML. THE SAMPLE WAS THEN REPEATED USING THE WAKO ACCURASEED METHOD, RESULTING IN A PTH VALUE OF 56 PG/ML. THE SAMPLE WAS PROVIDED FOR INVESTIGATION WHERE IT WAS TESTED WITH THE ELECSYS PTH ASSAY ON A COBAS E 801 MODULE ON (B)(6) 2023 RESULTING IN A PTH VALUE OF 405 PG/ML. NO QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16919277 ↗
• MalfunctionNov 30, 2022High Test Results; Low Test Results; High Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR FOUR SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH THE ELECSYS PTH IMMUNOASSAY ON A COBAS 8000 E 801 MODULE (SERIAL NUMBER (B)(4)). THE RESULTS DID NOT AGREE WITH THE PATIENT'S CLINICAL STATUS. IT WAS ASKED, BUT IT IS NOT KNOWN IF ANY INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST SAMPLE RESULTED IN A PTH VALUE OF 462 PG/ML WHEN TESTED ON THE E 801 ANALYZER ON (B)(6) 2022. THE SECOND SAMPLE RESULTED IN A PTH VALUE OF 440 PG/ML WHEN TESTED ON THE E 801 ANALYZER ON (B)(6) 2022. THE THIRD SAMPLE RESULTED IN A PTH VALUE OF 415 PG/ML WHEN TESTED ON THE E 801 ANALYZER ON (B)(6) 2022. THIS SAMPLE WAS TREATED WITH POLYETHYLENE GLYCOL (PEG) AND REPEATED ON THE E 801 ANALYZER ON (B)(6) 2022, RESULTING IN A RAW VALUE OF 17.5 PG/ML, WHICH CALCULATED TO A FINAL VALUE OF 35 PG/ML (8.4 % RECOVERY) WHEN ACCOUNTING FOR THE DILUTION FACTOR. THE FOURTH SAMPLE RESULTED IN A PTH VALUE OF 404 PG/ML WHEN TESTED ON THE E 801 ANALYZER ON (B)(6) 2022. THIS SAMPLE WAS REPEATED ON AN ARCHITECT ANALYZER, RESULTING IN A PTH VALUE OF 895.0 PG/ML ON (B)(6) 2022. THE PATIENT HAD NO CLINICALLY CONFIRMED PATHOLOGY RELA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15885036 ↗
• MalfunctionNov 21, 2022High Test Results; Non Reproducible Results; High Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS PTH IMMUNOASSAY RESULTS FROM TEN PATIENT SAMPLES TESTED ON THE COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE MEDICAL PERSONNEL CONTACTED THE LABORATORY COMPLAINING THAT THE RESULTS WERE HIGHER THAN EXPECTED. MOST OF THE SAMPLES WERE REPORTEDLY FROM POST-SURGERY PATIENTS AND THE PHYSICIANS WERE EXPECTING LOWER RESULTS FROM WHAT WAS RECEIVED BEFORE THE SURGERY. AS PART OF THE LABORATORY'S INVESTIGATION INTO THIS ISSUE, 10 PATIENT SAMPLES WERE SENT OUT TO TWO OTHER SITES WHICH ALSO USE THE E 801. THE REPORTER STATED THAT THE RESULTS FROM BOTH SITES WERE SIGNIFICANTLY LOWER FOR ALL THE PATIENT SAMPLES COMPARED TO THE INITIAL RESULTS THEY OBTAINED FROM THE ANALYZER. THE REPORTER STATED THAT THEY ARE NOW SENDING OUT THE PATIENT SAMPLES TO THESE SITES FOR PROCESSING UNTIL THE ISSUE IS RESOLVED. THE REPORTER WAS ONLY ABLE TO PROVIDE ONE EXAMPLE OF A DISCREPANT RESULT WITH ONLY ONE REPEAT RESULT FROM ONE OF THE SITES. THE INITIAL RESULT FROM THE ANALYZER USING THE PRIMARY TUBE WAS 103 PG/ML. THE REPEAT RESULT FROM THE OTHER SITE'S E 801 USING AN ALIQUOT SAMPLE WAS 78.68 PG/ML. THE REPEAT RESUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833921 ↗
• MalfunctionOct 31, 2022Incorrect Measurement; High Test Results; Low Test Results; Incorrect Measurement; High Test Results; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE ELECSYS PTH IMMUNOASSAY AND ELECSYS DHEA-S ON A COBAS 8000 E 801 MODULE. THE SAMPLE ALSO HAD A QUESTIONABLE PTH VALUE WHEN TESTED ON A SECOND E 801 ANALYZER. NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THIS MEDWATCH WILL APPLY TO THE PTH ASSAY. PLEASE REFER TO THE MEDWATCH WITH A1. PATIENT IDENTIFIER (B)(6) FOR INFORMATION RELATED TO THE DHEA-S ASSAY. THE SAMPLE INITIALLY RESULTED IN A PTH VALUE OF < 1.5 PG/ML WITH A DATA FLAG WHEN TESTED ON THE FIRST E 801 ANALYZER. THE SAMPLE WAS TESTED AGAIN ON A SECOND E 801 ANALYZER, RESULTING IN THE SAME VALUE. THE SAMPLE WAS FROZEN AND RE-TESTED APPROXIMATELY 1 WEEK LATER ON AN ABBOTT ALINITY ANALYZER, RESULTING IN A PTH VALUE OF 44.1 PG/ML. THE SAMPLE INITIALLY RESULTED IN A DHEA-S VALUE OF > 1000 UG/DL WITH A DATA FLAG WHEN TESTED ON THE FIRST E 801 ANALYZER. THE SAMPLE WAS DILUTED 1:10 AND REPEATED ON THE FIRST E 801 ANALYZER, RESULTING IN A VALUE OF APPROXIMATELY 1100 UG/DL. THE SAMPLE WAS FROZEN AND RE-TESTED APPROXIMATELY 1 WEEK LATER ON AN ABBOTT ALINITY ANALYZER, RESULTING IN A DHEA-S VALUE OF 211.4 UG/DL. THE RESUL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15703459 ↗
• MalfunctionJul 22, 2022Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results; Incorrect, Inadequate or Imprecise Result or Readings; Low Test Results; Non Reproducible Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS PTH RESULTS FOR ONE PATIENT TESTED WITH A COBAS 8000 E 801 MODULE. IT WAS REPORTED THE PTH CALIBRATION AND QC RESULTS WERE ACCEPTABLE. THE PATIENT'S INITIAL ELECSYS PTH RESULT WAS REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S PHYSICIAN QUESTIONED THE REPORTED RESULT AND EXPECTED THE PTH RESULT TO BE HIGHER BASED ON THE PATIENT'S CLINICAL PICTURE. IT WAS REPORTED THE PATIENT'S SAMPLE WAS ALSO TESTED WITH THE SIEMENS CENTAUR ASSAY AND THE ORTHO VITROS ASSAY. ALLEGEDLY THE ELECSYS AND SIEMENS RESULTS WERE BELOW THE REFERENCE INTERVAL, WHICH WAS UNEXPECTED. THE ORTHO VITROS PRODUCED AN ELEVATED RESULT. THE SPECIFIC PTH RESULTS FROM THE SIEMENS CENTAUR ASSAY AND THE ORTHO VITROS ASSAY WERE REQUESTED BUT NOT PROVIDED. THE PATIENT'S INITIAL ELECSYS PTH RESULT WAS 8.3 PG/ML. THE E 801 MODULE SERIAL NUMBER WAS UNSPECIFIED. THE PATIENT HAD A NEW SAMPLE COLLECTED AND THE ELECSYS PTH RESULT WAS 7.22 PG/ML. THE E 801 MODULE SERIAL NUMBER WAS (B)(4). THE PATIENT'S ELECSYS PTH RESULT WITH A 1:2 DILUTION WAS 10.6 PG/ML. THE E 801 MODULE SERIAL NUMBER WAS UNSPECIFIED. THE PATIENT'S ELECSYS PTH RESULT WITH A 1:3 DILUTION WAS 16.17 PG/ML. THE E 801

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15086986 ↗
• MalfunctionApr 19, 2022Incorrect Measurement; High Test Results; Incorrect Measurement; High Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED QUESTIONABLE RESULTS FOR TWO SAMPLES COLLECTED FROM THE SAME PATIENT AND TESTED WITH THE ELECSYS PTH IMMUNOASSAY ON A COBAS 8000 E 801 MODULE (SERIAL NUMBER (B)(4)). THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND QUESTIONED BY THE CLINICIAN. THE VALUE WAS EXPECTED TO BE VERY LOW AS THE PATIENT NO LONGER HAS A PARATHYROID GLAND. THE FIRST SAMPLE RESULTED IN A PTH VALUE OF 949.00 NG/L WHEN TESTED ON THE E 801 MODULE. THE SECOND SAMPLE RESULTED IN A PTH VALUE OF 931.00 NG/L WHEN TESTED ON THE E 801 MODULE ON (B)(6) 2022. THIS SAMPLE WAS ALSO TESTED ON AN ABBOTT ALINITY CI-SERIES ANALYZER, RESULTING IN A PTH VALUE OF < 4.0 PG/ML ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14142965 ↗
• MalfunctionSep 8, 2021Low Test Results; Low Test Results

  THERE WAS AN ALLEGATION OF QUESTIONABLE LOW ELECSYS PTH IMMUNOASSAY RESULTS FROM COBAS E801 MODULE SERIAL NUMBER (B)(4). THE PATIENT'S PTH WAS REPEATEDLY MEASURED IN AN INTERVAL OF ABOUT 1 MONTH. THE RESULT WAS ALWAYS AN IMPLAUSIBLY LOW VALUE THAT WAS LESS THAN THE MEASURING RANGE OF THE ASSAY. ONE EXAMPLE WAS PROVIDED OF A RESULT FROM A BECKMAN ANALYZER OF 20.2 NG/L. THE SAMPLE WAS FROZEN AND ONE MONTH LATER WAS TESTED ON THE COBAS E801 WITH A RESULT OF <1.2 NG/L. THE SPECIFIC DATE OF TESTING WAS NOT PROVIDED. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE RESULTS FROM THE BECKMAN ANALYZER WERE CONSIDERED CORRECT AS THEY FIT THE CLINICAL EXPECTATIONS OF THE MEDICAL DOCTOR IN CHARGE (NEPHROLOGIST).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12439009 ↗
• MalfunctionJul 30, 2021Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS PTH IMMUNOASSAY RESULTS FOR ONE PATIENT SAMPLE WITH THE COBAS E 801 MODULE (B)(4). THE INITIAL RESULT WAS 6 PG/ML. THIS RESULT WAS REPRODUCIBLE BUT CONSIDERED CLINICALLY IMPLAUSIBLE FOR THE PATIENT ACCORDING TO THE ATTENDING PHYSICIAN. THE PATIENT HAS BEEN ANALYZED TWO TIMES BETWEEN (B)(6) 2021 AND (B)(6) 2021 WITH LOW AND DECREASING PTH VALUES ON THE E 801. THE ORIGINAL SAMPLE WAS RE-ANALYZED ON AN ABBOTT ARCHITECT WITH A RESULT OF 27 PG/ML. THIS RESULT WAS CONSIDERED CLINICALLY PLAUSIBLE AND CORRECT. IT IS UNKNOWN IF THE QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12253457 ↗
• MalfunctionJul 7, 2021Incorrect Measurement; Low Test Results; Incorrect Measurement; Low Test Results

  THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR FIVE PATIENT SAMPLES TESTED WITH THE ELECSYS PTH IMMUNOASSAY ON A COBAS 8000 E 801 MODULE (SERIAL NUMBER (B)(4)). NO INCORRECT RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FIRST PATIENT SAMPLE INITIALLY RESULTED IN A PTH VALUE OF 12.1 PG/ML ON (B)(6) 2021, WHICH REPEATED AS 7.95 PG/ML ON (B)(6) 2021. THE SAMPLE WAS REPEATED USING AN UNKNOWN CHEMILUMINESCENCE METHOD, RESULTING IN A VALUE OF 16 PG/ML ON (B)(6) 2021. THE SECOND PATIENT SAMPLE INITIALLY RESULTED IN A PTH VALUE OF 11.2 PG/ML ON (B)(6) 2021, WHICH REPEATED AS 9.63 PG/ML ON (B)(6) 2021. THE SAMPLE WAS REPEATED USING AN UNKNOWN CHEMILUMINESCENCE METHOD, RESULTING IN A VALUE OF 15.40 PG/ML ON (B)(6) 2021. THE THIRD PATIENT SAMPLE INITIALLY RESULTED IN A PTH VALUE OF 4.65 PG/ML ON (B)(6) 2021, WHICH REPEATED AS 3.88 PG/ML ON (B)(6) 2021. THE SAMPLE WAS REPEATED USING AN UNKNOWN CHEMILUMINESCENCE METHOD, RESULTING IN A VALUE OF 20.20 PG/ML ON (B)(6) 2021. THE FOURTH PATIENT SAMPLE INITIALLY RESULTED IN A PTH VALUE OF 4.59 PG/ML ON (B)(6) 2021, WHICH REPEATED AS 5.39 PG/ML ON (B)(6) 2021. THE SAMPLE WAS REPEATED USING AN UNKNOWN CHEMILUMINESCENCE METHOD,

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12130490 ↗