BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1781496 · Received August 3, 2010

    Report

    Report Number
    1823260-2010-04570
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    July 26, 2010
    Report Date
    August 13, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT A NEONATE RECEIVED THE RESULT OF 46 MG/DL ON THE INFORM SYSTEM COMPARED BACK TO BACK WITHIN 10 MINUTES OF A RESULT OF 33 MG/DL OBTAINED ON A LAB SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Description of Event or Problem · 1

    THREE PTS HAD BLUE LINT IN THEIR EYES, ON THE LENS. TWO PTS HAD THE LINT REMOVED, BUT ONE PT STILL HAS LINT IN THEIR EYE CAUSING NO PROBLEMS, IT WILL BE REMOVED AT A LATER DATE.

    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 551284

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA