BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2800064 · Received October 17, 2012

    Report

    Report Number
    2183996-2012-01590
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 12, 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 OF 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 INSULIN DELIVERY OF THE INFUSION DEVICE HAS BEEN TOO LOW FOR THE PAST 14 DAYS. HE PROVIDED THE FOLLOWING EXAMPLE: HIS BLOOD GLUCOSE WAS 7.1 MMOL/L (127.8 MG/DL) ON (B)(6) 2012 AT 8:30 AM. HE ATE 2 BE AND DELIVERED 4 I.U. VIA THE INFUSION DEVICE. HIS BLOOD GLUCOSE WAS 15.3 MMOL/L (275.4 MG/DL) AT 12:00 AM AND HE DELIVERED 5-6 I.U. VIA THE INFUSION DEVICE. HIS BLOOD GLUCOSE WAS 22.3 MMOL/L (401.4 MG/DL) AT 3:00 PM AND HE DELIVERED 10 I.U. VIA SYRINGE. HIS BLOOD GLUCOSE WAS 19.8 MMOL/L (356.4 MG/DL) AT 3:30 PM. HE DID NOT HAVE AN INFECTION OR START NEW MEDICATION. THE INFUSION DEVICE WAS REQUESTED FOR EVAL. HE 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 69 YR INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP