BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2071806 · Received April 21, 2011

    Report

    Report Number
    2183996-2011-01154
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 25, 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
    WA, 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, PT REPORTED THAT SHE WAS EXPERIENCING "UNUSUALLY HIGH" BLOOD GLUCOSE AND WANTED TO BE SURE HER INFUSION DEVICE WAS FUNCTIONING PROPERLY. PT'S FRIEND HELPED WITH TROUBLESHOOTING AS PT IS BLIND. NO ALERTS OR ERRORS WERE REC'D ON THE INFUSION DEVICE. THIS BEGAN 2 WEEKS PRIOR TO THE REPORT, AND PT EXPERIENCED READINGS IN THE 400-500 MG/DL RANGE DURING THE PREVIOUS DAY. TARGET BLOOD GLUCOSE IS 80-145 MG/DL. ON (B)(6) 2011, PT BOLUSED AND DELIVERED INSULIN INJECTIONS OF OVER 36 UNITS TO CORRECT HYPERGLYCEMIA, BUT BLOOD GLUCOSE KEPT INCREASING. PT TYPICALLY TAKES 23-27 UNITS OF INSULIN IN A 24 HOUR PERIOD. THE TIME AND ONE BASAL RATE WERE NOT SET CORRECTLY ON THE INFUSION DEVICE, AND THIS WAS CORRECTED DURING THE TROUBLESHOOTING CALL. PT HAD A PARASITE THE WEEK PRIOR TO THE REPORT AND WAS RECEIVING TREATMENT, AND THE PARASITE AFFECTED HER DIGESTION. PT REPORTED THAT SHE WENT TO THE EMERGENCY ROOM ON (B)(6) 2011 AT 2 A.M. DUE TO HYPERGLYCEMIA AND DEHYDRATION. PT WAS GIVEN IV FLUIDS AND SENT HOME. ONCE PT WAS HYDRATED, HER BODY BECAME RESPONSIVE TO INSULIN. PT WOKE THE NEXT MORNING AND BLOOD GLUCOSE WAS ABOVE 180 MG/DL. PT DELIVERED 2 UNITS OF INSULIN THROUGH THE INFUSION DEVICE AND BLOOD GLUCOSE WAS 240 MG/DL THE NEXT HOUR. PT THEN DELIVERED A 6 UNIT INSULIN INJECTION AND BLOOD GLUCOSE KEPT INCREASING. F/U WAS COMPLETED WITH PT ON (B)(6) 2011. PT REPORTED THAT SHE HAD AN ABSCESSED TOOTH AND THAT SHE AND HER PHYSICIAN BELIEVE THAT WAS THE CAUSE OF HYPERGLYCEMIA. BLOOD GLUCOSE HAS SINCE STABILIZED. NO PRODUCT WAS REQUESTED FOR EVALUATION.

    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 58 YR Hospitalization| R INSULIN INFUSION SET| INSULIN