BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2232514 · Received August 25, 2011

    Report

    Report Number
    2183996-2011-02304
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 14, 2011
    Report Date
    August 14, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, WIFE REQUESTED ASSISTANCE ADJUSTING BASAL RATES ON THE INFUSION DEVICE. PT IS IN A HOSPICE PROGRAM BUT CONTINUED TO WEAR THE INFUSION DEVICE. ENDOCRINOLOGIST SET THE HOURLY BASAL RATE TO 0.7 UNITS, AND WIFE ASKED IF THE HOURLY BASAL RATE SHOULD BE CHANGED TO 0.5 UNITS DUE TO A SEVERE HYPOGLYCEMIC EPISODE ON THE DAY OF THE REPORT. WIFE WAS ADVISED TO SPEAK WITH A MEDICAL PROFESSIONAL REGARDING BASAL RATE CHANGES, AND WIFE REPORTED THAT DAUGHTER HAD ALREADY MADE THE CHANGES. WIFE REPORTED PT IS NOT VERY RESPONSIVE. HIS BLOOD GLUCOSE WAS 46 MG/DL EARLIER IN THE DAY, AND SHE PUT SUGAR IN APPLE SAUCE AND GAVE IT TO HIM. BLOOD GLUCOSE ELEVATED TO 49 MG/DL AND THEN TO 50 MG/DL AFTER 30 MINUTES HAD PASSED. BLOOD GLUCOSE WAS 60 MG/DL AFTER AN ADDITIONAL 30 MINUTES AND WAS 81 MG/DL AFTER 3 HRS. PT WOULD NOT EAT ANYMORE FOOD. NORMAL BLOOD GLUCOSE IS 120-130 MG/DL. WIFE REPORTED THAT PT ¿DOESN¿T HARDLY EAT¿ AND HASN¿T FOR THE PAST FEW WEEKS, AND SHE BELIEVES THIS IS THE REASON FOR HYPOGLYCEMIA. TROUBLESHOOTING DID NOT REVEAL ANY PRODUCT ISSUES. F/U WAS COMPLETED WITH WIFE ON (B)(6) 2011. WIFE SPOKE WITH NURSE AND PHYSICIAN AND WAS ADVISED TO DISCONTINUE USE OF THE INFUSION DEVICE. THEY WILL CONTINUE TO MONITOR PT¿S BLOOD GLUCOSE AND STATE OF DIABETES. WIFE REPORTED PT WAS UNRESPONSIVE WHEN HE EXPERIENCED HYPOGLYCEMIA. NO PRODUCT WAS REQUESTED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention INSULIN INFUSION SET| INSULIN