BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2982057 · Received February 8, 2013

    Report

    Report Number
    2183996-2013-00183
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 24, 2013
    Report Date
    March 28, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NOT APPLICABLE

    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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCT MEETS THE SPECIFICATION REGARDING THE CUSTOMER'S ALLEGATION. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED. NO MALFUNCTION OF THE PUMP COULD BE OBSERVED. ALWAYS A W2 (BATTERY LOW) BEFORE E2 (BATTERY DEPLETED). TRANSFER DATA TO SMART PIX WORKS. NO HIGH POWER CONSUMPTION. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    MOTHER REPORTED, THE POWER HAS OCCASIONALLY CUT-OFF ON THE INFUSION DEVICE, AND THE BATTERY HAS TO BE CHANGED EVERY WEEK. ON ONE OCCASION, THE INFUSION DEVICE FAILED TO PROVIDE A W2 BATTERY LOW WARNING BEFORE THE E2 BATTERY EMPTY ERROR. MOTHER REPORTED, THE PT IS ACTIVE AND SPENDS A LOT OF TIME OUTSIDE WHERE THE TEMPERATURE IS VERY LOW. MOTHER ALSO REPORTED, THE INFUSION DEVICE WILL NOT TRANSFER DATA TO THE COMPUTER. THE HOSPITAL HAS TRIED MULTIPLE DEVICES TO TRANSFER THE DATA, BUT THIS HAS NOT BEEN SUCCESSFUL. THE INFUSION DEVICE WAS REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED, AND HE DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55279 ACCU-CHEK SPIRIT COMBO LZG ROCHE HEALTH SOLUTIONS INC. 00700006863 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR RELATED ACCESSORIES| INSULIN INFUSION PUMP| INSULIN