BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2991281 · Received March 6, 2013

    Report

    Report Number
    1823260-2013-01339
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 13, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH IS FOR THE COMPACT PLUS SYSTEM. REFERENCE MEDWATCH WITH (B)(6) FOR THE AVIVA NANO SYSTEM.

    Description of Event or Problem · 1

    REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON TWO DIFFERENT METERS WITHIN 1 MINUTE: 214 MG/DL (COMPACT PLUS) AND 114 MG/DL (AVIVA NANO). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95192 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 208060

    Patients

    Seq Age Sex Outcome Treatment
    1 029 YR