BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1030573 · Received April 15, 2008

    Report

    Report Number
    2183996-2008-00490
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 28, 2008
    Report Date
    March 28, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 REPORTED THAT HE WAS NOT ABLE TO PRIME PROPERLY THIS EVENING. HE STATED THAT HE PERFORMED TWO PRIMES WITH HIS INFUSION DEVICE AND NO INSULIN DRIPPED FROM THE END OF THE INFUSION TUBING. HE THEN FOUND THAT THE INSULIN COMPARTMENT OF THE INFUSION DEVICE WAS FILLED WITH INSULIN. HE STATED THAT APPROX 100 UNITS OF INSULIN SPILLED FROM THE BOTTOM OF THE INSULIN CARTRIDGE. HE SWITCHED TO HIS BACKUP INFUSION DEVICE. AT THE TIME OF THE REPORT THE PT STATED THAT HIS INFUSION DEVICE APPEARED TO BE DRY. HE STATED THAT HE WAS USING EXPIRED INSULIN CARTRIDGES. HE WAS ADVISED AGAINST USING EXPIRED PRODUCT. UPON FOLLOW UP THREE DAYS LATER, THE PT STATED THAT HIS INFUSION DEVICE SHOWED NO SIGNS OF MOISTURE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT 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 INSULIN| INSULIN INFUSION SET