BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 3127200 · Received May 23, 2013

    Report

    Report Number
    1823260-2013-03160
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    February 21, 2013
    Report Date
    August 13, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CUSTOMER REPORTED COMPACT PLUS SYSTEM BLOOD GLUCOSE RESULTS. ALL MG/DL: (B)(6) 2013 17:17 106, (B)(6) 2013 17:16 146, (B)(6) 2013 17:14 81, (B)(6) 2013 17:13 447, (B)(6) 2012 8:11 114, (B)(6) 2012 8:08 94, (B)(6) 2012 8:06 289, (B)(6) 2012 22:26 104, (B)(6) 2012 22:24 204, (B)(6) 2011 14:38 114, (B)(6) 2011 14:35 234. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228425 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR