BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® MULTICLIX

    MDR report key: 1791984 · Received August 10, 2010

    Report

    Report Number
    1823260-2010-04723
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 23, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FMK
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT THE CUSTOMER COULD NOT USE THE MULTICLIX LANCET DEVICE AS IT WOULD NOT PUNCTURE HER FINGER. REPORTER STATED THAT WHEN THE CUSTOMER COULD NOT GET IT TO WORK, SHE STARTED ACTING FUNNY, HAD DIFFICULTY STAYING AWAKE, AND HAD SLURRED SPEECH. REPORTER STATED THAT AN AMBULANCE WAS CALLED, THEY OBTAINED A RESULT OF 34 OR 39 MG/DL ON THEIR SYSTEM AND THEN GAVE HER SOME SORT OF SHOT. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. A REQUEST WAS MADE FOR THE RETURN OF THE SUSPECT DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ISSUE WITH THEIR METER WHICH SUGGESTS THE MEMORY OVERWRITE MALFUNCTION HAS OCCURRED. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MULTICLIX LANCET DEVICE FMK ROCHE DIAGNOSTICS NA GWW095

    Patients

    Seq Age Sex Outcome Treatment
    1 075 YR Required Intervention FAST ACTING INSULIN| LANTUS (DAILY)