BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1837055 · Received September 16, 2010

    Report

    Report Number
    1823260-2010-05513
    Event Type
    Malfunction
    Date Received
    September 16, 2010
    Date of Event
    August 28, 2010
    Report Date
    September 16, 2010
    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. MEDWATCH(B)(6) IS FOR INFORM SYSTEM (B)(4).

    Description of Event or Problem · 1

    CALLER FROM INFORM SYSTEM USER FACILITY REPORTED PATIENT BLOOD GLUCOSE RESULTS: LAB 0945 171 MG/DL LAB 0947 159 MG/DL INFORM (B)(4) 0951 527 MG/DL INFORM (B)(4) 0954 599 MG/DL INFORM (B)(4) 0955 553 MG/DL INFORM (B)(4) 0956 598 MG/DL INFORM (B)(4) 0957 563 MG/DL SHE DOES NOT KNOW IF THE PATIENT RECEIVED ANY TREATMENT BASED ON THE METER READINGS. THERE WAS NO REPORT OF ADVERSE EFFECT TO THE PATIENT BASED ON THE METER RESULTS. A REQUEST WAS MADE FOR THE RETURN OF THE STRIPS, REPLACEMENT 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 551262

    Patients

    Seq Age Sex Outcome Treatment
    1 077 YR VENTILATOR