BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM II TEST STRIPS

    MDR report key: 4092522 · Received September 16, 2014

    Report

    Report Number
    1823260-2014-07037
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    July 26, 2014
    Report Date
    September 17, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K121679
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE INFORM SYSTEM WITHIN 10 MINUTES: 37 MG/DL, 53 MG/DL, AND 55 MG/DL. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT STRIPS AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573054 ACCU-CHEK ® INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 473013

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA NO MEDICATIONS OR OTHER MEDICAL DEVICES