BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INFORM EU PLASMA TEST STRIPS

    MDR report key: 1770679 · Received October 29, 2007

    Report

    Report Number
    1823260-2007-09424
    Event Type
    Malfunction
    Date Received
    October 29, 2007
    Date of Event
    August 30, 2007
    Report Date
    October 29, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NBW
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    REPORTER STATED THAT PATIENT'S BLOOD GLUCOSE MEASURED >30.0 MMOL/L (EXACT VALUE NOT PROVIDED) ON THE INFORM SYSTEM. AN ADDITIONAL SAMPLE OBTAINED FROM THE SAME PATIENT REPORTEDLY MEASURED 7.8 MMOL/L IN THE FACILITY'S LAB. REPORTER DID NOT INDICATE IF PATIENT WAS TREATED BASED ON THE VALUE OBTAINED ON THE INFORM SYSTEM. NO ADVERSE EVENT WAS REPORTED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK INFORM EU PLASMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - NA NBW ROCHE DIAGNOSTICS 549555

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK METFORMIN HCL 500 MG| TOLBUTAMIDE 500 MG| ASCAL SACHET 300 MG| FUROSEMIDE 40 MG| LIPITOR 20 MG| TILDIEM CR 90 MG