BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT PLUS TEST DRUM

    MDR report key: 4687678 · Received April 14, 2015

    Report

    Report Number
    1823260-2015-02973
    Event Type
    Malfunction
    Date Received
    April 14, 2015
    Date of Event
    March 17, 2015
    Report Date
    June 17, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K113614
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 75 2:34 PM ON (B)(6) 2015 106 2:34 PM ON (B)(6) 2015 122 2:34 PM ON (B)(6) 2015 126 2:35 PM ON (B)(6) 2015 114 2:35 PM ON (B)(6) 2015 127 2:36 PM ON (B)(6) 2015 121 2:38 PM ON (B)(6) 2015 105 2:39 PM ON (B)(6) 2015 116 2:39 PM ON (B)(6) 2015 95 2:40 PM ON (B)(6) 2015 104 2:41 PM ON (B)(6) 2015. NO DEATH OR SERIOUS INJURY REPORTED. REQUESTED RETURN OF SUSPECT DEVICE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247114 ACCU-CHEK ® COMPACT PLUS TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20811451

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR NO MEDICATIONS