BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 3840460 · Received May 30, 2014

    Report

    Report Number
    1823260-2014-03855
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE COMPACT PLUS SYSTEM (LOT NUMBER 20732642, EXPIRATION DATE UNKNOWN). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN THE MOBILE SYSTEM. DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY VIAL WAS RETURNED. IN ADDITION, PRODUCT WAS EXPIRED AT TIME OF EVENT.

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE COMPACT PLUS SYSTEM (LOT NUMBER 20732642, EXPIRATION DATE UNKNOWN). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN THE MOBILE SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FEELING UNWELL AND WAS SWEATY. HE TESTED 19.8 MMOL/L ON THE MOBILE SYSTEM AT 00:17; AT 00:20 HE INJECTED "TORONTO" INSULIN AND TESTED 3.7 MMOL/L ON THE COMPACT PLUS SYSTEM AT 00:30. THE CUSTOMER RECEIVED RESULTS OF 4.0 MMOL/L (00:33) AND 10.0 MMOL/L (00:34) ON THE MOBILE SYSTEM. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318731 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20732642

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR "TORONTO" INSULIN