BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INFORM II TEST STRIPS

    MDR report key: 3914199 · Received July 3, 2014

    Report

    Report Number
    1823260-2014-04922
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 9, 2014
    Report Date
    August 14, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K121679
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 REPORTED INFORM II BLOOD GLUCOSE RESULTS OF 21 MG/DL AND 31 MG/DL, LAB RESULT OF 169 MG/DL WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391052 ACCU-CHEK ® INFORM II TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 473011

    Patients

    Seq Age Sex Outcome Treatment
    1 079 YR SULFAMETHOXAZOLE-TRIMETHOPRIM