BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1071414 · Received July 7, 2008

    Report

    Report Number
    2183996-2008-00995
    Event Type
    Injury
    Date Received
    July 7, 2008
    Date of Event
    June 29, 2008
    Report Date
    June 29, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TYPE OF INFUSION SET IN USE AT THE TIME OF THE INCIDENT IS UNK. NO PROD WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED RECEIVING AN E4 (OCCLUSION) ERROR ON HIS INFUSION DEVICE. HE STATED THAT HIS BLOOD GLUCOSE MEASURED "HI" ON HIS BLOOD GLUCOSE MONITOR A FEW HOURS PRIOR TO THE REPORT. HE BOLUSED 8 UNITS OF INSULIN VIA SYRINGE AND AN HOUR LATER, HIS BLOOD GLUCOSE STILL MEASURED "HI". HE ATTEMPTED TO BOLUS THROUGH HIS INFUSION DEVICE AND REC'D THE E4 ERROR. HE CHANGED THE INSULIN CARTRIDGE AND BOLUSED AGAIN VIA SYRINGE. HIS NORMAL BLOOD GLUCOSE RANGE IS 100-200 MG/DL. HIS BLOOD GLUCOSE AT THE TIME OF THE REPORT MEASURED 217 MG/DL. TO TROUBLESHOOT, HE WAS INSTRUCTED TO DISCONNECT FROM HIS INFUSION SITE AND TO PERFORM A PRIME. HE REC'D AN E4. HE WAS INSTRUCTED TO REMOVE THE INFUSION TUBING AND HE WAS ABLE TO PRIME THROUGH THE ADAPTER WITHOUT ERROR. HE THEN ATTACHED NEW INFUSION TUBING AND WAS ABLE TO PRIME WITHOUT ERROR. UPON F/U ON THE NEXT DAY, HE STATED THAT HIS BLOOD GLUCOSE HAD RETURNED TO NORMAL. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PROD WILL BE RETURNED FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention INSULIN INFUSION PUMP| INSULIN