BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM II TEST STRIPS

    MDR report key: 3910642 · Received July 2, 2014

    Report

    Report Number
    1823260-2014-04864
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 4, 2014
    Report Date
    July 29, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K121679
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER RECEIVED REPORTS REGARDING THIS INFORM II SYSTEM AND DISCREPANT RESULTS. 20:27 YESTERDAY = HI, WHICH ON THE SYSTEM INDICATES A RESULT IN EXCESS OF 600 MG/DL 20:31 YESTERDAY = 214 TODAY 7:32AM = 494 TODAY 7:47AM = 218 NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388187 ACCU-CHEK ® INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 472123

    Patients

    Seq Age Sex Outcome Treatment
    1 051 YR