BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2564299 · Received May 2, 2012

    Report

    Report Number
    2183996-2012-00595
    Event Type
    Malfunction
    Date Received
    May 2, 2012
    Date of Event
    April 25, 2012
    Report Date
    April 26, 2012
    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
    GM
    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.

    Description of Event or Problem · 1

    MOTHER REPORTED, THE UP BUTTON ON THE INFUSION DEVICE HAS A LOOSE CONNECTION. PT'S BLOOD GLUCOSE WAS 111 MG/DL ON (B)(6) 2012 AT 6:45 P.M., AND PT ATE 3 KE. MOTHER ADMINISTERED 1.2 I.U. OF INSULIN VIA THE INFUSION DEVICE, AND PT'S BLOOD GLUCOSE THEN ELEVATED TO 284 MG/DL AT 8:00 P.M. MOTHER ATTEMPTED TO REWIND THE PISTON ROD, BUT THE INFUSION DEVICE DID NOT RESET TO 315 I.U. MOTHER REPORTED THE PISTON ROD "MOVED AUTOMATICALLY FORWARD," AND SHE PRESSED THE CHECK BUTTON TO STOP IT. THE PT SWITCHED TO THE BACKUP INFUSION DEVICE AT 8:00 PM. MOTHER DOES NOT KNOW IF THE INFUSION DEVICE WAS DROPPED. THE INFUSION DEVICE WAS REPLACED AND REQUESTED FOR EVAL. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT COMBO LZG ROCHE INSULIN DELIVERY SYSTEMS INC 00700006863 NA

    Patients

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