BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2971705 · Received January 30, 2013

    Report

    Report Number
    2183996-2013-00123
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    December 28, 2012
    Report Date
    April 18, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE SERIAL NUMBER IS NOT AVAILABLE, THE COMPLAINT COULD NOT BE REPRODUCED. RESULT PUMP: AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE SERIAL NUMBER IS NOT AVAILABLE, THE COMPLAINT COULD NOT BE REPRODUCED. ADAPTER: NO ADAPTER WAS AVAILABLE FOR INVESTIGATION. CARTRIDGE: SINCE NO MATERIAL HAS BEEN RETURNED FROM THE CUSTOMER AND NO LOT NUMBER IS KNOWN, NO INVESTIGATION COULD BE PERFORMED. THEREFORE THE COMPLAINT CANNOT BE VERIFIED. CORRECTIVE ACTIONS AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE SN IS NOT AVAILABLE, THE COMPLAINT COULD NOT BE REPLICATED. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT REPORTED THAT HE HAD BEEN WAKING UP WITH ELEVATED BLOOD GLUCOSE LEVELS FOR THE PAST THREE WEEKS; HE BELIEVES THE INFUSION DEVICE IS NOT DELIVERING HIS BASAL RATES CORRECTLY. THE PT STATED THAT IN THE MORNINGS HIS BLOOD GLUCOSE LEVELS HAVE BEEN IN THE 300'S MG/DL. HE STATED THAT HIS TARGET IS NO MORE THAN 140 MG/DL. HE HAS BEEN TREATING THE ELEVATED LEVELS WITH INJECTIONS OF INSULIN. HE STATED THAT THE BOLUS FUNCTION ON THE DEVICE WORKS PROPERLY. ON (B)(6) 2013, HE CALLED PARAMEDICS TO CHECK HIS BLOOD GLUCOSE LEVEL. HE WAS NOT TREATED BY THE PARAMEDICS AND WAS ABLE TO TREAT HIMSELF FOR THE ELEVATED BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WITH THE PT DID NOT IDENTIFY ANY PROBLEMS WITH THE INFUSION DEVICE AND THE PT HAS NOT HAD ANY LIFESTYLE CHANGES. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION DEVICE, ADAPTER, INSULIN CARTRIDGE, AND INFUSION SET WERE REQUESTED TO BE RETURNED FOR PRODUCT EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41996 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTIONS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR INSULIN INFUSION PUMP| INSULIN| RELATED ACCESSORIES