BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT COMBO

    MDR report key: 2151660 · Received June 28, 2011

    Report

    Report Number
    2183996-2011-01955
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    LZG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT REPORTED WAKING UP ON (B)(6) 2011 AT 8:30 AM TO FIND HER INSULIN CARTRIDGE LEAKING INSULIN. PATIENT STATED SHE DID A FULL SET CHANGE AND TESTED HER BLOOD GLUCOSE LEVEL WITH A READING OF 17.0 MMOL/L (306 MG/DL). PATIENT REPORTED ON THE SAME DAY AT 6:45 PM SHE WENT INTO KETOACIDOSIS AND THE AMBULANCE WAS CALLED. PATIENT STATED SHE WAS ADMITTED TO THE HOSPITAL AT 7 PM AND TESTED HER BLOOD GLUCOSE ON THE HOSPITAL METER WITH A READING OF 17.9 MMOL/L (322 MG/DL). PATIENT REPORTED AT THE SAME TIME USING THE SAME METER SHE DID A KETONE TEST AND RECEIVED A READING OF 5.4. PATIENT STATED THE HOSPITAL DISCONNECTED HER INFUSION DEVICE AND PUT HER ON AN INFUSION DRIP THAT SAME NIGHT. PATIENT REPORTED SHE STAYED OVERNIGHT IN THE HOSPITAL AND THE NEXT MORNING ON (B)(6) 2011 SHE DID A FULL SET CHANGE AND TESTED ON THE HOSPITAL METER WITH A READING OF 15.0 MMOL/L (270 MG/DL). PATIENT STATED AT 12 PM SHE DID ANOTHER BLOOD GLUCOSE TEST AND GOT A READING OF AROUND 20.0 MMOL/L (360 MG/DL) AND A KETONE RESULT OF 0.3. PATIENT REPORTED SHE IS NOW IN STABLE CONDITION AND HER BLOOD GLUCOSE LEVELS WENT DOWN (RESULTS UNKNOWN). PATIENT STATED SHE WAS HOSPITALIZED FOR 5 DAYS. PATIENT STATED SHE IS NOT SURE IF THE PROBLEM WAS THE INFUSION DEVICE OR THE INFUSION SET. PATIENT REPORTED SHE NO LONGER HAS THE ALLEGED INFUSION SETS. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Hospitalization| O| R INSULIN INFUSION SET: (TX DATE (B)(6))| INSULIN (DATE OF TX: (B)(6))