BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1172185 · Received September 18, 2008

    Report

    Report Number
    2183996-2008-01431
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED RECEIVING AN E4 (OCCLUSION) ERROR WHILE ATTEMPTING TO BOLUS FOR ELEVATED BLOOD GLUCOSE. HE STATED THAT HIS BLOOD GLUCOSE MEASURED 66 MG/DL WHEN HE WOKE UP. HE STATED THAT HIS READING WAS LOW, BECAUSE HE HAD NOT EATEN ENOUGH THE NIGHT BEFORE. HE ATE BREAKFAST WITHOUT BOLUSING AND HIS BLOOD GLUCOSE ELEVATED TO 214 MG/DL 30 MINUTES LATER. HIS NORMAL BLOOD GLUCOSE RANGE IS 100-150 MG/DL. TO TROUBLESHOOT THE PATIENT WAS INSTRUCTED TO DISCONNECT FROM HIS INFUSION SITE AND TO PERFORM A BOLUS. HE WAS ABLE TO DO SO WITHOUT ERROR. HE WAS THEN INSTRUCTED TO REPLACE HIS INFUSION SITE. HE STATED THAT THE CANNULA OF THE INFUSION SITE APPEARED TO BE "KINKED". THE PATIENT INSERTED A NEW INFUSION SITE AND WAS ABLE TO BOLUS WITHOUT ERROR. UPON FOLLOW UP ON 09/08/2008 THE PATIENT STATED HE HAD NO FURTHER ISSUES. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OF SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO 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 8E004UF

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR INSULIN| INSULIN INFUSION PUMP