BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM II TEST STRIPS

    MDR report key: 3254032 · Received July 30, 2013

    Report

    Report Number
    1823260-2013-04571
    Event Type
    Malfunction
    Date Received
    July 30, 2013
    Date of Event
    July 1, 2013
    Report Date
    August 13, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K121679
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    CALLER STATES THAT THE FOLLOWING READINGS WERE OBTAINED ON A NEONATE PATIENT, USING THE INFORM II SYSTEM COMPARED TO A LAB RESULT, WITHIN 10 MINUTES: 33 MG/DL, 54 MG/DL (INFORM II) AND 71 MG/DL (LAB). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. PATIENT WAS BREAST-FED AND THEN SUPPLEMENTED WITH FORMULA. NO ADVERSE EVENT REPORTED. CALLER STATES THAT THE ALCOHOL MAY NOT HAVE BEEN DRY PRIOR TO THE HEELSTICK. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354648 ACCU-CHEK ® INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 471207

    Patients

    Seq Age Sex Outcome Treatment
    1 001 DA