BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1132011 · Received August 19, 2008

    Report

    Report Number
    2183996-2008-01255
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 6, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    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 EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED EXPERIENCING AN E4 (OCCLUSION) ERROR ON HER INFUSION DEVICE. SHE STATED THAT SHE DISCONNECTED FROM HER INFUSION SITE AND PRIMED BUT THE E4 RECURRED. HER BLOOD GLUCOSE WAS ELEVATED TO OVER 200 MG/DL AND SHE BOLUSED 8 UNITS OF INSULIN SUCCESSFULLY PRIOR TO THE REPORT. SHE BEGAN EXPERIENCING E4 ERRORS 2 MONTHS AGO DURING BASAL DELIVERY. SHE STATED THAT SHE CHANGED THE BATTERY TODAY. SHE CHANGES THE BATTERY EVERY 2 WEEKS. SHE WAS ASSISTED WITH CHANGING HER INFUSION TUBING AND SHE WAS ABLE TO PRIME WITHOUT ERROR. HER BLOOD GLUCOSE MEASURED 178 MG/DL. HER NORMAL BLOOD GLUCOSE RANGE IS 80-120 MG/DL. UPON FOLLOW UP TWO DAYS LATER, THE PATIENT REPORTED THAT SHE EXPERIENCED 2 MORE E4 ERRORS. SHE STATED THAT HER INSULIN CARTRIDGE WAS ALMOST EMPTY. THE E4 DID NOT RECUR AFTER CHANGING THE INSULIN CARTRIDGE. 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 ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS NA 8C202UF

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION PUMP| INSULIN