BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK® COMFORT CURVE TEST STRIPS

    MDR report key: 1801406 · Received August 16, 2010

    Report

    Report Number
    1823260-2010-04831
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    August 6, 2010
    Report Date
    September 1, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PPH PROCEDURE, THE STAPLER ONLY APPLIED THE POSTERIOR HEMICIRCUMFERENCE OF THE STAPLES. THE ANTERIOR PART WAS CUT BUT NOT SUTURED. THE CASE WAS COMPLETED BY MANUALLY SUTURING. NO ADVERSE PATIENT CONSEQUENCES.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE ADVANTAGE SYSTEM WITHIN 10 MINUTES: 417 MG/DL, 301 MG/DL, AND 172 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE; HOWEVER, CUSTOMER NO LONGER HAS ANY STRIPS USED DURING THE INCIDENT. 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 551238

    Patients

    Seq Age Sex Outcome Treatment
    1 NOVOLOG