BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2946147 · Received February 6, 2013

    Report

    Report Number
    1823260-2013-00723
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    January 15, 2013
    Report Date
    March 6, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH IS FOR THE COMPACT PLUS SYSTEM 2. REFERENCE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE COMPACT PLUS SYSTEM 1. DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE USED STRIPS WERE RETURNED.

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. THIS MEDWATCH IS FOR THE COMPACT PLUS SYSTEM 2. REFERENCE MEDWATCH WITH (B)(6) FOR THE COMPACT PLUS SYSTEM 1.

    Description of Event or Problem · 1

    CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT METERS, WITHIN 10 MINUTES: 13 MG/DL, 19 MG/DL (COMPACT PLUS SYSTEM 1) AND 130 MG/DL (COMPACT PLUS SYSTEM 2). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49616 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20732941

    Patients

    Seq Age Sex Outcome Treatment
    1 070 YR CALCIUM| ASPIRIN| SIMVASTATIN| GLUCOSAMINE| METFORMIN| LISINOPRIL