BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1081220 · Received July 23, 2008

    Report

    Report Number
    2183996-2008-01046
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 30, 2008
    Report Date
    June 30, 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
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT'S WIFE REPORTED THAT THE PT IS EXPERIENCING ELEVATED BLOOD GLUCOSE. SHE STATED THAT THE PT ATE LUNCH AND BOLUSED 10 UNITS OF INSULIN AND 30 MINUTES LATER, HIS BLOOD GLUCOSE MEASURED 520 MG/DL. THE PT'S INSULIN CARTRIDGE AND INFUSION SET WAS CHANGED ON THE DAY BEFORE AND ALL INSULIN BUBBLES WERE PRIMED OUT. THE PT WAS UNAVAILABLE FOR TROUBLESHOOTING. UPON FOLLOW UP ON THE FOLLOWING MONTH, THE PT'S WIFE STATED THAT THE PT'S BLOOD GLUCOSE HAD RETURNED TO NORMAL AND THAT SHE HAD MISTAKENLY FILLED THE PT'S INSULIN CARTRIDGE WITH SALINE INSTEAD OF INSULIN. 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 Other| R INSULIN INFUSION SET| INSULIN