BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 2142901 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01847
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    June 5, 2011
    Report Date
    June 6, 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
    IN, 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, COMPANY REPRESENTATIVE REPORTED THAT PT WAS HOSPITALIZED FOR HYPOGLYCEMIA. FOLLOW-UP WAS COMPLETED WITH PT ON (B)(6) 2011. PT REPORTED THAT HIS BLOOD GLUCOSE DECREASED TO 25 MG/DL ON (B)(6) 2011. HE "PASSED OUT" AND AN AMBULANCE WAS CALLED. PT WAS TREATED WITH "SUGAR WATER" AND WAS ADMITTED TO THE HOSPITAL UNTIL (B)(6) 2011. PT WAS TAKEN OFF THE INFUSION DEVICE AND TREATED WITH AN INSULIN DRIP AT THE HOSPITAL. TARGET BLOOD GLUCOSE IS 115 MG/DL. BASAL RATES WERE DECREASED, AND PT RESTARTED THE INFUSION DEVICE ON (B)(6) 2011 AND HAS NOT FACED FURTHER HYPOGLYCEMIA. PT REPORTED THAT DAY HE HAD COMPANY AND ACCIDENTALLY MISSED A MEAL, AND HE BELIEVES THAT CONTRIBUTED TO HYPOGLYCEMIA. PT REPORTED HE HAD BEEN IN A HOT SHOWER BEFORE THE EVENT AND THAT HIS BASAL RATES WERE PROGRAMMED TOO HIGH. INFUSION DEVICE WAS NOT DROPPED, CRACKED, OR EXPOSED TO WATER OR OTHER LIQUID. 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 73 YR Hospitalization| R INSULIN INFUSION SET| INSULIN (DATE OF TX (B)(6))| (DATE OF TX (B)(6))