BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1193213 · Received October 7, 2008

    Report

    Report Number
    2183996-2008-01541
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 25, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FOZ
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 RECEIVING SEVERAL E4 (OCCLUSION) ERRORS OVER THE PAST 3 DAYS. THE MOST RECENT E4 OCCURRED WHILE ATTEMPTING TO BOLUS 5 UNITS OF INSULIN FOR LUNCH. THE INFUSION SITE AND TUBING WAS CHANGED TWO DAYS PRIOR. SHE STATED THAT WHEN SHE REMOVED THE INFUSION SITE, THE CANNULA WAS BENT. TO TROUBLESHOOT, SHE WAS INSTRUCTED TO DISCONNECT FROM HER INFUSION SITE AND TO BOLUS 4 UNITS OF INSULIN. SHE RECEIVED AN E4 AFTER 1.4 UNITS WERE DELIVERED. SHE WAS INSTRUCTED TO REMOVE THE INFUSION TUBING AND SHE WAS ABLE TO BOLUS WITHOUT ERROR. SHE WAS DRIVING AND STATED THAT SHE DID NOT HAVE REPLACEMENT PRODUCT WITH HER. SHE WAS EDUCATED ON ALTERNATIVE INFUSION SITES AND SENT INFORMATION ON INFUSION SITE MANAGEMENT. UPON FOLLOW UP SIX DAYS LATER, THE PATIENT STATED THAT SHE HAD NO FURTHER ISSUES SINCE CHANGING HER ACCESSORIES. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS DISCARDED. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TENDER INFUSION SET INSULIN INFUSION SET FOZ DISETRONIC MEDICAL SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR INSULIN INFUSION PUMP| INSULIN