BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2175410 · Received July 25, 2011

    Report

    Report Number
    1823260-2011-03970
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    July 10, 2011
    Report Date
    September 19, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 ALLEGED THAT THE FOLLOWING RESULTS WERE OBTAINED ON A NEONATE PATIENT LESS THAN 10 MINUTES APART: 1. 29 MG/DL (INFORM METER) AND 1 MG/DL (LAB) 2. 50 MG/DL (INFORM METER) AND 36 MG/DL (LAB) SETS OF READINGS WERE TAKEN AT DIFFERENT TIMES ON THE SAME DAY. NEONATE PATIENT WAS SYMPTOMATIC OF HYPOGLYCEMIA AT THE TIME OF THE READINGS. NEONATE IS ON A DIET OF INTRAVENOUS SOLUTION ONLY, NOTHING BY MOUTH (NPO). NEONATE WAS TREATED WITH DETROSE 10% SOLUTION INTRAVENOUSLY BASED UPON THE METER READING. NO ADVERSE EVENT REPORTED. NEONATE WAS TRANSFERRED TO A PEDIATRIC FACILITY. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551514

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA IV SOLUTION - TYPE UNKNOWN