BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2832887 · Received November 14, 2012

    Report

    Report Number
    1823260-2012-05770
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 22, 2012
    Report Date
    November 30, 2012
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    CALLER STATES THAT A PATIENT REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON AN INFORM METER, COMPARED TO LAB RESULTS, WITHIN 10 MINUTES: 569 MG/DL (INFORM) AND 186 MG/DL (LAB). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. CALLER STATES 2 VIALS WITH SAME LOT WERE STORED NEAR DEVICE AND IS NOT SURE WHICH VIAL WAS USED. REQUESTED RETURN OF SUSPECT STRIPS (BOTH VIALS), AND 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 551735

    Patients

    Seq Age Sex Outcome Treatment
    1 087 YR HUMALOG - SLIDING SCALE| LINEZOLID| NORMAL SALINE FLUSH| FINASTERIDE| PROTONIX| CLINDAMYCIN| SODIUM CHLORIDE