BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS B 101 HBA1C TEST

    MDR report key: 9429521 · Received December 6, 2019

    Report

    Report Number
    1823260-2019-04302
    Event Type
    Malfunction
    Date Received
    December 6, 2019
    Date of Event
    November 13, 2019
    Report Date
    December 19, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LCP
    PMA / PMN Number
    K163633
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER DID NOT RETURN ANY MATERIALS FOR INVESTIGATION. WITHOUT THESE MATERIALS TO INVESTIGATE, A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. RETENTION MATERIAL OF COBAS B101 HBA1C LOT 931043-01 WAS TESTED WITH WHOLE BLOOD MEASUREMENTS AND HELD AGAINST TARGET VALUES OBTAINED FROM A TOSOH G8 INSTRUMENT: A) EIGHT LOW WHOLE BLOOD SAMPLES WERE MEASURED WITH RETENTION MATERIAL OF COBAS B101 HBA1C LOT 931043-01 ON A RETENTION COBAS B101 INSTRUMENT. B) EIGHT MIDDLE WHOLE BLOOD SAMPLES WERE MEASURED WITH RETENTION MATERIAL OF COBAS B101 HBA1C LOT 931043-01 ON A RETENTION COBAS B101 INSTRUMENT. THE PRODUCT MEETS SPECIFICATION. RETENTION MATERIAL TESTING AND MANUFACTURER FINAL PRODUCT INSPECTION WERE SUCCESSFUL. THE RETENTION MATERIAL MEASUREMENTS ON THE RETENTION COBAS B101 INSTRUMENT SHOWED NO HBA1C DEVIATION COMPARED TO TOSOH G8.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE RESULT HEMOGLOBIN A1C RESULTS FOR THREE PATIENT SAMPLES FROM COBAS B 101 INSTRUMENT SERIAL NUMBER (B)(4). THE SAMPLES WERE REPEATED IN ANOTHER LABORATORY WITH AN UNKNOWN METHOD. PATIENT 1: B101 RESULT WAS 7.9% AND THE REPEAT RESULT WAS 7.2%. PATIENT 2: B101 RESULT WAS 7.3% AND THE REPEAT RESULT WAS 6.5%. PATIENT 3: B101 RESULT WAS 8.3% AND THE REPEAT RESULT WAS 7.4%. THE QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227016 COBAS B 101 HBA1C TEST ASSAY, GLYCOSYLATED HEMOGLOBIN LCP ROCHE DIAGNOSTICS B 101 HBA1C 931043-012

    Patients

    Seq Age Sex Outcome Treatment
    1