BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS B 101 HBA1C TEST

    MDR report key: 9446524 · Received December 10, 2019

    Report

    Report Number
    1823260-2019-04365
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 18, 2019
    Report Date
    December 26, 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

    RETENTION MATERIAL OF COBAS B101 HBA1C TEST DISCS OF LOT 931043-01 WAS TESTED AND NO DISCREPANT HBA1C RESULTS WERE RECEIVED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S METER WAS TESTED WITH QC MATERIAL. LEVEL 1: PASS, 5.1%, RANGE 4.3-6.5. LEVEL 2: PASS, 8.6%, RANGE 7.4-11.2. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED A QUESTIONABLE HEMOGLOBIN A1C RESULT FOR ONE PATIENT SAMPLE FROM THE COBAS B 101 INSTRUMENT SERIAL NUMBER (B)(4). THE RESULT FROM THE B101 WAS 7.1 %. THE RESULT FROM ANOTHER LABORATORY USING AN UNKNOWN METHOD WAS 6.4 %. IT WAS NOT KNOWN IF ANY QUESTIONABLE RESULT WAS REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240528 COBAS B 101 HBA1C TEST ASSAY, GLYCOSYLATED HEMOGLOBIN LCP ROCHE DIAGNOSTICS B 101 HBA1C 931043-01

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR