Sample supply unit 09793178001Recalls & reported problems
Roche Diagnostics GmbH · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613336220146), received between May 14, 2024 and Jan 15, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Non Reproducible Results” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Non Reproducible Results2
- High Test Results1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2026Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Non Reproducible Results
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH THE SODIUM ELECTRODE ON A COBAS C 303 ANALYTICAL UNIT. THE SAMPLE INITIALLY RESULTED IN A SODIUM VALUE OF 125 MMOL/L. THE RESULT DID NOT MATCH THE PATIENT'S HISTORY, SO THE SAMPLE WAS REPEATED ON A SECOND ANALYZER. THE REPEAT RESULT WAS 133 MMOL/L AND WAS DEEMED CORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24077913 ↗MalfunctionDec 10, 2025High Test Results; High Test Results
THE INITIAL REPORTER NOTICED QC FOR BILT3 BILIRUBIN TOTAL GEN.3 (BILT3) TRENDING HIGHER ON THEIR COBAS PURE SAMPLE SUPPLY UNIT. THE CUSTOMER REPLACED THE REAGENT PACK AND REPEATED 6-8 PATIENT SAMPLES. A DISCREPANT HIGH BILT3 RESULT WAS PROVIDED FOR 1 PATIENT SAMPLE. THE INITIAL RESULT WAS 1.9 MG/DL. THE REPEAT RESULT WAS 0.2 MG/DL. THE REPEAT RESULT WAS BELIEVED TO BE CORRECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23769332 ↗MalfunctionMay 14, 2024Non Reproducible Results; Non Reproducible Results
THE INITIAL REPORTER QUESTIONED THE RESULTS FOR ROCHE DIAGNOSTICS MAGNESIUM REAGENT (MG2), CREATINE, AND ALT FOR MULTIPLE PATIENT SAMPLES TESTED ON A COBAS PURE INSTRUMENT. THE CUSTOMER PROVIDED EXAMPLES OF DISCREPANT RESULTS FOR 2 PATIENT SAMPLES TESTED FOR MG2. PATIENT 1 INITIAL RESULT WAS 3.2 MG/DL. THE REPEAT RESULT WAS 2.3 MG/DL. PATIENT 2 INITIAL RESULT WAS 2.9 MG/DL. THE REPEAT RESULT WAS 2.0 MG/DL. THE SAMPLES WERE REPEATED AS THE INITIAL RESULTS DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL HISTORY. THE REPEAT RESULTS WERE BELIEVED TO BE CORRECT. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19313173 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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