BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 3162262 · Received June 11, 2013

    Report

    Report Number
    1823260-2013-03518
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 16, 2013
    Report Date
    July 19, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. REFERENCE THE FOLLOWING MEDWATCHES WITH (B)(6) PATIENT IDENTIFIERS FOR THE FOLLOWING SYSTEMS: (B)(6) - COMPACT PLUS SYSTEM 1 (B)(6) - COMPACT PLUS SYSTEM 2 (B)(6) - COMPACT PLUS SYSTEM 3.

    Description of Event or Problem · 1

    CALLER STATES THAT THE FOLLOWING READINGS WERE OBTAINED ON A STAFF MEMBER, COMPARED TO A PROFESSIONAL DEVICE, WITHIN 10 MINUTES: 40S-RANGE MG/DL (PROFESSIONAL DEVICE), AND 90S-RANGE MG/DL, 100S-RANGE MG/DL, AND 100S-RANGE MG/DL (COMPACT PLUS). IT IS UNKNOWN WHICH OF THREE COMPACT PLUS METERS USED IN THE COMPARISON GAVE WHICH RESULT. STAFF MEMBER ATE A BAGEL ON HER OWN AND WAS FEELING FINE. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. CALLER STATES THAT CONTROLS WERE NOT RUN ON THE COMPACT PLUS DEVICES WITHIN 24 HOURS OF THE INCIDENT. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262100 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1