BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 2970125 · Received February 20, 2013

    Report

    Report Number
    1823260-2013-01077
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 29, 2013
    Report Date
    March 27, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    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. REFERENCE THE FOLLOWING MEDWATCHES WITH PATIENT IDENTIFIERS FOR THE HOSPITAL STAFF MEMBER WITH FOLLOWING METER/STRIP COMBINATIONS: (B)(6) FOR INFORM METER (B)(4), COMFORT CURVE STRIP LOT 551844 (B)(4) FOR INFORM METER (B)(4), COMFORT CURVE STRIP LOT 551844 (B)(4) FOR INFORM METER (B)(4), COMFORT CURVE STRIP LOT 551844.

    Description of Event or Problem · 1

    CALLER STATES THAT A HOSPITAL STAFF MEMBER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE INFORM SYSTEM WITHIN 10 MINUTES: 130 MG/DL, 141 MG/DL (INFORM SYSTEM 1 - (B)(4)) AND 272 MG/DL, 139 MG/DL (INFORM SYSTEM 2 - (B)(4)) AND 129 MG/DL, 161 MG/DL (INFORM SYSTEM 3 - (B)(4)). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72919 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 551844

    Patients

    Seq Age Sex Outcome Treatment
    1