BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1243169 · Received November 7, 2008

    Report

    Report Number
    2183996-2008-01697
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 29, 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
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT HE COULD SEE A SMALL AMOUNT OF CONDENSATION IN THE CARTRIDGE COMPARTMENT OF HIS INFUSION DEVICE. HE ATTEMPTED TO DRY THE CARTRIDGE COMPARTMENT WITH A COTTON SWAB BUT STATED THERE WAS A SMALL AMOUNT OF CONDENSATION HE WAS UNABLE TO REACH. HE WAS ADVISED TO SWITCH TO HIS BACKUP INFUSION DEVICE AND TO ALLOW THE PRIMARY DEVICE TO DRY FOR 24 HOURS. HE REPORTED THAT HE DOES NOT ATTACH THE INFUSION TUBING AND ADAPTER TO THE INSULIN CARTRIDGE PRIOR TO INSERTION INTO THE INFUSION DEVICE. HE WAS EDUCATED ON THE PROPER PROCEDURE. UPON FOLLOW UP IN THE NEXT DAY, THE PATIENT STATED THAT THE CARTRIDGE COMPARTMENT WAS COMPLETELY DRY. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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 52 YR INSULIN INFUSION SET| INSULIN