ONLINE TDM Vancomyin Gen.3 06779344190Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04015630934447), received between Jan 28, 2019 and Feb 11, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 reports).

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.

• MalfunctionFeb 11, 2022Low Test Results; Low Test Results

  THERE WAS A COMPLAINT OF QUESTIONABLE VANCOMYCIN RESULTS FOR 4 PATIENTS TESTED WITH COBAS 6000 C501 MODULE SERIAL NUMBER (B)(4). THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PHARMACIST QUESTIONED THE RESULTS WHICH PROMPTED A REPEAT. THE PATIENTS¿ SAMPLES WERE REPEATED FOR A SECOND TIME ON A DIFFERENT C501 MODULE. PATIENT 1¿S INITIAL RESULT WAS < 4.0 UG/ML ACCOMPANIED BY A DATA FLAG; THE FIRST REPEAT RESULT WAS 4.2 UG/ML, THE SECOND REPEAT WAS 11.1 UG/ML. PATIENT 2¿S INITIAL AND FIRST REPEAT RESULTS WERE < 4.0 UG/ML ACCOMPANIED BY A DATA FLAG; THE SECOND REPEAT WAS 20.3 UG/ML. PATIENT 3¿S INITIAL RESULT WAS < 4.0 UG/ML ACCOMPANIED BY A DATA FLAG; THE FIRST REPEAT RESULT HAD NO NUMERICAL VALUE BUT WAS FLAGGED BY A DATA FLAG, THE SECOND REPEAT WAS 19.7 UG/ML. PATIENT 4¿S INITIAL AND FIRST REPEAT RESULTS WERE < 4.0 UG/ML ACCOMPANIED BY A DATA FLAG; THE SECOND REPEAT WAS 14.6 UG/ML. THE CUSTOMER BELIEVES THE SECOND REPEATED RESULT TO BE CORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13516053 ↗
• MalfunctionSep 17, 2021Low Test Results; Low Test Results

  THE INITIAL REPORTER RECEIVED QUESTIONABLE VANC3 VANCOMYCIN RESULTS FOR ONE PATIENT ON THREE DIFFERENT SAMPLES WITH THE COBAS 6000 C501 MODULE SERIAL NUMBER 19A4-14. SAMPLE 1: ON 21-AUG-2021, THE INITIAL RESULT WAS 0 UG/ML WITH A FLAG INDICATING UNUSUAL KINETICS. THE SAMPLE WAS DILUTED WITH A RESULT OF <4 UG/ML. ON 27-AUG-2021, THE SAMPLE WAS TESTED ON A FUJIREBIO G1200 WITH A RESULT OF 11.00 UG/ML. SAMPLE 2: ON 24-AUG-2021, THE INITIAL RESULT WAS 0 UG/ML WITH A FLAG INDICATING UNUSUAL KINETICS. THE SAMPLE WAS DILUTED WITH A RESULT OF <4 UG/ML. ON 27-AUG-2021, THE SAMPLE WAS TESTED ON A FUJIREBIO G1200 WITH A RESULT OF 14.40 UG/ML. SAMPLE 3: ON 27-AUG-2021, THE INITIAL RESULT WAS 0 UG/ML WITH A FLAG INDICATING UNUSUAL KINETICS. THE SAMPLE WAS PERFORMED ON 1:10, 1:20, 1:40, AND 1:200 DILUTION WITH RESULTS OF <4 UG/ML. ON 27-AUG-2021, THE SAMPLE WAS TESTED ON A FUJIREBIO G1200 WITH A RESULT OF 30.6 UG/ML. ON 08-SEP-2021, ALL THREE SAMPLES WERE SENT TO AN INVESTIGATION LAB FOR TESTING WITH RESULTS OF 0 UG/ML WITH A FLAG INDICATING UNUSUAL KINETICS. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE FUJIREBIO G1200 RESULTS ON 21-AUG-2021 AND 24-AUG-2021 WERE DEEMED C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12488636 ↗
• MalfunctionApr 26, 2019High Test Results; High Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENTS. ERRONEOUS HIGH RESULTS WERE GENERATED BY A COBAS 8000 C 502 MODULE. THE EVENT INVOLVED 1 PATIENT WITH VANC3 VANCOMYCIN. THE PROVIDED PATIENT'S AGE WAS (B)(6) YEARS. THE PATIENT WAS A FEMALE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8556134 ↗
• MalfunctionJan 28, 2019Low Test Results; Low Test Results

  THIS REPORT SUMMARIZES <NOE>1</NOE> MALFUNCTION EVENT. ERRONEOUS LOW RESULTS WERE GENERATED BY TWO COBAS 4000 C (311) STAND ALONE SYSTEMS. THE EVENT INVOLVED A TOTAL OF 2 PATIENTS WITH ERRONEOUS RESULTS FOR VANC3 VANCOMYCIN. THE AGES OF THE PATIENTS WERE REQUESTED BUT WERE NOT PROVIDED. THE WEIGHTS OF THE PATIENTS WERE REQUESTED BUT WERE NOT PROVIDED THE GENDERS OF THE PATIENTS WERE REQUESTED BUT WERE NOT PROVIDED. THE RACES OF THE PATIENTS WERE REQUESTED BUT WERE NOT PROVIDED. THE ETHNICITIES OF THE PATIENTS WERE REQUESTED BUT WERE NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8281617 ↗

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-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
• 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