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AU OSR6221Recalls & reported problems

Beckman Coulter, Inc. · Glucose · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15099590020101), received between May 17, 2018 and May 17, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “High Test Results” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • High Test Results1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 17, 2018High Test Results; High Test Results

    THE CUSTOMER REPORTED HAVING ISSUES WITH GLUCOSE (GLU) ON THEIR AU5800 CHEMISTRY ANALYZER. THE CUSTOMER ESTIMATED 500 GLU PATIENT RESULTS WERE HIGH BUT ONLY TWO PATIENT RESULTS WERE PROVIDED. THE PATIENT SAMPLES WERE REDRAWN AND REPEATED ON THE SAME AU AND ANOTHER AU INSTRUMENT AND BOTH RESULTS WERE LOWER. ORIGINAL HIGH RESULTS WERE REPORTED OUT OF THE LABORATORY BUT INSTEAD OF CORRECTING THE RESULTS, THE CUSTOMER ATTACHED A NOTE TO THE RESULTS. THE CUSTOMER CONFIRMED PATIENT TREATMENT WAS NOT IMPACTED. QUALITY CONTROL (QC) WAS WITHIN THEIR ESTABLISHED RANGE BEFORE THE EVENT; HOWEVER, QC WAS OUT OF RANGE AFTER THE EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7523165 ↗

Other Hexokinase, Glucose devices

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.