ONLINE TDM Vancomycin Gen.3 08445605190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613336157800), received between Sep 15, 2021 and Dec 20, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K152245); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 20, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THERE WAS AN ALLEGATION OF QUESTIONABLE VANC2 VANCOMYCIN RESULTS FOR 2 PATIENT SAMPLES ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER WAS PROMPTED TO REPEAT THE SAMPLES AFTER QC WAS PERFORMED AND WAS OUTSIDE OF THE ACCEPTABLE RANGE. FOR PATIENT 1, THE INITIAL VANC2 RESULT WAS 11.9 UG/ML. THE SAMPLE WAS REPEATED IN DUPLICATE ON ANOTHER ANALYZER AND THE RESULTS WERE 9.2 UG/ML AND 9.5 UG/ML. FOR PATIENT 2, THE INITIAL VANC2 RESULT WAS 10.6 UG/ML. THE SAMPLE WAS REPEATED IN DUPLICATE ON ANOTHER ANALYZER AND THE RESULTS WERE 8.3 UG/ML AND 8.0 UG/ML. THE REPEAT RESULTS WERE DEEMED CORRECT. THE ANALYZER SERIAL NUMBER IS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16016297 ↗
• MalfunctionSep 12, 2022Non Reproducible Results; Non Reproducible Results

  THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ONLINE TDM VANCOMYCIN GEN.3 (VANC3) ON A COBAS PRO C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 6.64 UG/ML. THIS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. AN ADDITIONAL RESULT OF 6.68 UG/ML WAS ALSO PROVIDED FOR THIS SAMPLE. ON (B)(6) 2022 A NEW SAMPLE WAS OBTAINED AND THE RESULTS WERE 14.7 UG/ML AND 14.8 UG/ML. THESE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. DUE TO THESE RESULTS, THE INITIAL RESULT WAS QUESTIONED. ON (B)(6) 2022 THE ORIGINAL SAMPLE WAS REPEATED AND THE RESULT WAS 9.63 UG/ML. THIS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THE C503 UNIT SERIAL NUMBER WAS (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15402131 ↗
• MalfunctionApr 28, 2022High Test Results; High Test Results

  THE INITIAL REPORTER STATED THEY HAVE BEEN HAVING ISSUES WITH VANC3 VANCOMYCIN RECOVERY ON THE COBAS PRO C 503 ANALYTICAL UNIT. CONTROL RECOVERY WILL GO HIGHER AND THEN THEY HAVE TO RECALIBRATE. AFTER RECALIBRATING, THE CUSTOMER WILL PULL PATIENT SAMPLES THAT WERE PREVIOUSLY TESTED AND REPEAT THESE. THE REPORTER PROVIDED DATA FOR ONE PATIENT SAMPLE THAT HAD DISCREPANT VANCOMYCIN RESULTS. THE SAMPLE INITIALLY RESULTED IN A VANCOMYCIN VALUE OF 48.8 UG/ML AND THIS VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE WAS PULLED AND REPEATED AFTER CONTROLS WENT HIGH AND THE ASSAY WAS RECALIBRATED. THE REPEAT RESULT WAS 38 UG/ML ON (B)(6) 2022. THE REPEAT VALUE WAS DEEMED CORRECT AND A CORRECTED REPORT WAS ISSUED. THE SERIAL NUMBER OF THE C 503 ANALYZER IS 2190-03.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240668 ↗
• MalfunctionSep 15, 2021Low Test Results; Low Test Results

  THERE WAS A COMPLAINT OF DISCREPANT VANCOMYCIN IMMUNOASSAY RESULTS FOR ONE PATIENT BETWEEN TWO COBAS 6000 C501 MODULE SERIAL NUMBERS (B)(4) AND A BM NANOPIA (SEKISUI) USING ONLINE TDM VANCOMYCIN GEN.3. ON (B)(6) 2021, THE INITIAL RESULTS GAVE AN UNKNOWN NUMERIC VALUE AND HAD AN ALARM INDICATING UNUSUAL REACTION KINETICS. THE SAMPLE WAS CENTRIFUGED AND THE SAME RESULT WAS OBTAINED; THE NUMERICAL RESULT WAS REQUESTED BUT NOT PROVIDED. THE SAMPLE WAS DILUTED AND RESULTED IN THE ALARM INDICATING UNUSUAL REACTION KINETICS. THE RESULTS WERE THE SAME FOR BOTH COBAS 6000 C501 MODULES. ON (B)(6) 2021, THE SAMPLE WAS REPEATED ON A COBAS AND PRODUCED A RESULT OF 4.8 UG/ML. ON (B)(6) 2021, THE CUSTOMER TOOK A NEW BLOOD SAMPLE FROM THE PATIENT AND RAN THE NEW SAMPLE. THE RESULT WAS 4.8 UG/ML ON THE COBAS C501. THE RESULT WAS AROUND 19-20 UG/ML ON THE BM NANOPIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475904 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152245. One submission often covers many models, so check the product and lot details in each record.

• Z-0043-2020 · Jul 23, 2019 · Terminated
  Online TDM Vancomycin Gen.3 ( 200 tests) Catalog # 06779344190 Analyzer/Module: cobas c 311 and cobas c 501/502
• Z-0042-2020 · Jul 23, 2019 · Terminated
  Online TDM Vancomycin Gen.3 (100 tests) Catalog # 06779336190 Analyzer/Module: cobas c 311 and cobas c 501/502