BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1402583 · Received June 12, 2009

    Report

    Report Number
    2183996-2009-01083
    Event Type
    Injury
    Date Received
    June 12, 2009
    Date of Event
    May 15, 2009
    Report Date
    May 15, 2009
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FOZ
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2009, THE PT REPORTED RECEIVING AN E4 (OCCLUSION) ERROR WHILE ATTEMPTING TO BOLUS. SHE CONFIRMED AND CLEARED THE ERROR BUT SHE DID NOT CHANGE ANY OF HER ACCESSORIES. LATER SHE HAD A "DRY MOUTH" AND HER BLOOD GLUCOSE WAS ELEVATED TO 25 MMOL/L (450 MG/DL). SHE ATTEMPTED TO BOLUS AND E4 WAS DISPLAYED. SHE WAS INSTRUCTED TO DISCONNECT FROM THE INFUSION TUBING AND SHE PRIMED WITHOUT ERROR. SHE INSERTED A NEW INFUSION SITE AND BOLUSED WITHOUT ERROR. THE INFUSION SITE HAD BEEN IN USE FOR 1 DAY. HER TARGET BLOOD GLUCOSE RANGE IS 5-6 MMOL/L (90-108 MG/DL). THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL.

    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 601295

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention INSULIN INFUSION PUMP| INSULIN