BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    MDR report key: 1083636 · Received July 29, 2008

    Report

    Report Number
    1823260-2008-05848
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    July 9, 2008
    Report Date
    July 29, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS FOR SUSPECT DEVICE ACCU-CHEK INFORM SYSTEM 1. REFERENCE MEDWATCH WITH A1 PT FOR SUSPECT DEVICE ACCU-CHEK INFORM SYSTEM 2.

    Description of Event or Problem · 1

    THE PT PRESENTED WITH ALTERED MENTAL STATUS. THE PT WAS TESTED AND THE FOLLOWING BLOOD GLUCOSE COMPARISONS WERE OBTAINED: 207MG/DL (ACCU-CHEK INFORM SYSTEM 1) AND 56MG/DL (LAB); 228MG/DL (ACCU-CHEK INFORM SYSTEM 2) AND 92MG/DL (LAB); 181MG/DL (ACCU-CHEK INFORM SYSTEM 1), 188MG/DL (ACCU-CHEK INFORM SYSTEM 2), AND 72MG/DL (LAB). ALL AFOREMENTIONED TESTS WERE OBTAINED WITHIN 10 MINS. THE PT WAS TREATED WITH D50 AFTER THE LAB RESULTS OF 56MG/DL AND 72MG/DL. HIS MENTAL STATUS IMPROVED DRAMATICALLY AFTER THE SECOND DOSE OF D50. NEW SYSTEM SENT TO CUSTOMER AND RETURN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 550050

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR MINOXIDIL 10 MG EVERY AM| PROMETHAZINE 1-2 TEASPOONS - AS NEEDED| PHOSLO 667 MG - 3 TIMES DAILY| METOPROLOL 100 MG TWICE DAILY| LISINOPRIL 40MG TWICE DAILY| LEVEMIR 25 UNITS INJECTION-EVERY AM| LEVEMIR-10 UNITS INJECTION-10PM| GUAIFENESIN WITH CODEINE 10ML - 3 TIMES DAY| REGLAN 10 MG - 3 TIMES A DAY| NOVOLOG 6 UNITS INJECTION-BEFORE MEALS| SODIUM BICARB 650 MG-TWICE DAILY