Etest® MEROPENEMRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03573026546984), received between Sep 24, 2020 and Sep 24, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (2 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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT MEROPENEM SUSCEPTIBLE RESULTS WHEN TESTING KLEBSIELLA PNEUMONIA STRAINS ISOLATED FROM A PATIENT'S SAMPLE USING ETEST® METHOD (REF. 513848, LOT 1007583220). THE CUSTOMER STATED THEY INOCULATED THE SUSPENSION OF THE MICROORGANISM ISOLATED FROM THE PATIENT'S SAMPLE INTO BIOMÉRIEUX MHE AGAR AND APPLIED THE MEROPENEM ETEST STRIP LOT 1007583220; AFTER INCUBATION THE CUSTOMER OBTAINED A MEROPENEM MIC VALUE OF 0.25 G/ML, CATEGORIZING THE STRAIN TO BE SUSCEPTIBLE TO THIS ANTIMICROBIAL AGENT. THE CUSTOMER MENTIONED THAT A SUSPENSION OF THE SAME MICROORGANISM ISOLATED FOR THE SAME PATIENT'S WAS TESTED FOR ANTIBIOTIC SUSCEPTIBILITY TEST USING VITEK® 2 AST-GN79 TEST KIT (REF. 413436) AND A MIC >16 G/ML WAS OBTAINED THAT CATEGORIZED THE STRAIN TO BE RESISTANT TO MEROPENEM. THE CUSTOMER ALSO PERFORMED CARBANP TEST FOR CARBAPENEMASE DETECTION AND A POSITIVE RESULT WAS OBTAINED; THIS IS NOT CONSISTENT WITH THE SUSCEPTIBLE RESULT TO MEROPENEM. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10581120 ↗
• MalfunctionSep 24, 2020Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  A CUSTOMER FROM THE UNITED STATES NOTIFIED BIOMÉRIEUX OF DISCREPANT MEROPENEM SUSCEPTIBLE RESULTS WHEN TESTING KLEBSIELLA PNEUMONIA STRAINS ISOLATED FROM A PATIENT'S SAMPLE USING ETEST® METHOD (REF. 513848, LOT 1007735480). THE CUSTOMER STATED THEY HAD INOCULATED THE SUSPENSION OF THE MICROORGANISM ISOLATED FROM THE PATIENT'S SAMPLE INTO BIOMÉRIEUX MHE AGAR AND APPLIED THE MEROPENEM STRIP LOT 1007735480; AFTER INCUBATION THE CUSTOMER OBTAINED A MEROPENEM MIC VALUE OF 0.25 G/ML, CATEGORIZING THE STRAIN TO BE SUSCEPTIBLE TO THIS ANTIMICROBIAL AGENT. THE CUSTOMER INDICATED THAT THEY HAD ALSO PERFORMED CARBANP TEST FOR CARBAPENEMASE DETECTION AND A POSITIVE RESULT WAS OBTAINED; THIS IS NOT CONSISTENT WITH THE SUSCEPTIBLE RESULT TO MEROPENEM. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10581078 ↗