ONLINE TDM Amikacin 08105383190Recalls & reported problems
Roche Diagnostics GmbH · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613336133514), received between Apr 11, 2023 and May 24, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (1 report).
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
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
- Low Test Results1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 24, 2023Low Test Results; Output Problem; Low Test Results; Output Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE AMIK GEN.2 (AMIKACIN) RESULT FROM COBAS PRO C 503 ANALYTICAL UNIT SERIAL NUMBER (B)(6). THE INITIAL RESULT WAS 69.8 G/ML WITH A DATA FLAG. THE REPEAT RESULT WITH AN ANALYZER DILUTION WAS 71.4 G/ML WITH A DATA FLAG. THE CUSTOMER PERFORMED A MANUAL 1:2 DILUTION AND THE RESULT WAS 29.8 G/ML. THE QUESTIONABLE RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16994469 ↗MalfunctionApr 11, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE INITIAL REPORTER RECEIVED QUESTIONABLE AMIKACIN RESULTS FROM TWO PATIENT SAMPLES TESTED ON THE COBAS PURE C 303 ANALYTICAL UNIT WITH SERIAL NUMBER (B)(4). THE REPORTER COMPLAINED THAT THE RESULTS BETWEEN THE COBAS PURE AND THE COBAS INTEGRA WERE DIFFERENT. THE INITIAL RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. PATIENT 1 ON (B)(6) 2023, THE INITIAL RESULT FROM THE COBAS INTEGRA WAS 2.3 UG/ML. ON (B)(6) 2023, THE REPEAT RESULT FROM THE COBAS PURE WAS 5.2 UG/ML. PATIENT 2 ON (B)(6) 2023, THE INITIAL RESULT FROM THE COBAS INTEGRA WAS 2.0 UG/ML. ON (B)(6) 2023, THE REPEAT RESULT FROM THE COBAS PURE WAS 5.0 UG/ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16712200 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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