BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2210197 · Received July 8, 2011

    Report

    Report Number
    2183996-2011-01969
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 28, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED THE VIBROALARM ON THE INFUSION DEVICE DOES NOT WORK. ON F/U CALL, THE PT'S MOTHER REPORTED THE INFUSION DEVICE STOPPED GIVING VIBRATION WARNINGS ABOUT A WEEK BEFORE THE CALL. MOTHER STATED THE PT NOTICED IT SINCE HE IS USE TO FEELING THE VIBRATIONS. PT REPORTED WHEN HE TAPPED WITH A FINGER ON ONE END OF THE INFUSION DEVICE, IT WOULD VIBRATE, OR AT LEAST GIVE A NOISE, OTHERWISE NOT. MOTHER STATED THE PT IS VERY CAREFUL WITH HIS INFUSION DEVICE AND KNOWS IT WELL. MOTHER REPORTED WHEN THE PT NOTICED THE VIBRATION MISSING ISSUE, HE JUST USED THE DEVICE WITH MORE AWARENESS. NO FURTHER INFO IS AVAILABLE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION DEVICE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG ROCHE INSULIN DELIVERY SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION SET| INSULIN