BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2932128 · Received January 18, 2013

    Report

    Report Number
    2183996-2012-02163
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Date of Event
    December 26, 2012
    Report Date
    June 13, 2013
    Manufacturer
    ROCHE HEALTH SOLUTINS INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT CANNOT BE VERIFIED, THE PRODUCTION DATA SHOWS NO DEVIATIONS OF THE SPECIFICATIONS. RESULT PUMP: AS THE PRODUCT HAS NOT BEEN RETURNED FOR INVESTIGATION AND THE PRODUCTION DATA COMPLY WITH THE SPECIFICATION, THE COMPLAINT COULD NOT BE REPLICATED. PRODUCTION REPORTS WERE REVIEWED. METER: NO PRODUCT IS EXPECTED TO BE RETURNED RELATED TO THIS CASE. UNABLE TO MAKE FURTHER STATEMENTS BECAUSE PRODUCT IS NOT AVAILABLE FOR ADDITIONAL INVESTIGATION THE CUSTOMER'S ALLEGATIONS OF THE INFUSION DEVICE DID NOT CORRECTLY DELIVER A BOLUS AND HIGH POWER CONSUMPTION COULD NOT BE TESTED FOR AS NO PRODUCT IS EXPECTED TO BE RETURNED RELATED TO THIS CASE. THIS CASE IS SET TO NOT VERIFIED, NO INVESTIGATION POSSIBLE BASED ON THE IU'S INABILITY TO TEST FOR THE CUSTOMER ALLEGATION. AS THE PRODUCT HAS NOT RETURNED FOR EVALUATION, THE COMPLAINT COULD NOT BE INVESTIGATED. DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, PATIENT REPORTED THE INFUSION DEVICE DID NOT CORRECTLY DELIVER A BOLUS AND THIS CAUSED HYPERGLYCEMIA. HE TESTED HIS BLOOD GLUCOSE, ENTERED THE CARBOHYDRATE AMOUNT, AND CALCULATED A BOLUS ON THE BLOOD GLUCOSE METER. THE RECOMMENDED BOLUS WAS 10.2 UNITS OF INSULIN, AND HE CONFIRMED THE AMOUNT AND PRESSED THE BUTTON TO DELIVER. THE METER COUNTED DOWN THE BOLUS AMOUNT AND RETURNED TO THE MAIN MENU SCREEN. THE COMMUNICATION SYMBOL WAS DISPLAYED ON THE METER AND INFUSION DEVICE. NO ALERTS/ERRORS WERE PROVIDED TO INDICATE THE BOLUS WAS NOT DELIVERED. HIS BLOOD GLUCOSE ELEVATED TO 398 MG/DL IN THE EVENING, AND HIS TARGET RANGE IS 100-140 MG/DL HIS "BODY FELT TOXIC," AND HE DELIVERED A 12.0 UNIT INSULIN INJECTION. THE 10.2 UNIT BOLUS WAS RECORDED IN THE METER HISTORY BUT WAS NOT REFLECTED IN THE INFUSION DEVICE HISTORY. HE ALSO REPORTED HIGH POWER CONSUMPTION WITH THE METER AND SAID THE BATTERIES HAVE BEEN CHANGED 3 TIMES IN THE PAST MONTH. HE BELIEVES THIS IS RELATED TO THE FAULTY BOLUS DELIVERY. THE INFUSION DEVICE AND METER WERE REPLACED AND REQUESTED FOR EVALUATION. 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
    28393 ACCU-CHEK SPIRIT LZG ROCHE HEALTH SOLUTINS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR INSULIN| RELATED ACCESSORIES| INSULIN INFUSION PUMP