BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1192445 · Received October 7, 2008

    Report

    Report Number
    2183996-2008-01538
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 20, 2008
    Report Date
    September 21, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FOZ
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT HER BLOOD GLUCOSE WAS ELEVATED OVER 500 MG/DL AND SHE FELT THIRSTY AND NAUSEATED. SHE ATTEMPTED TO BOLUS AND REC'D AN E4 (OCCLUSION) ERROR. SHE CHANGED THE INSULIN CARTRIDGE AND REC'D ANOTHER E4 WHILE PRIMING THE INFUSION TUBING. THE INFUSION TUBING HAD BEEN IN USE FOR 1 DAY. THE PT WAS INSTRUCTED TO REMOVE THE INFUSION TUBING, AND SHE WAS ABLE TO PRIME WITHOUT ERROR. SHE ATTACHED A NEW INFUSION TUBING AND SHE WAS ABLE TO PRIME WITHOUT ERROR. SHE RECONNECTED TO THE INFUSION SITE AND BOLUSED 12 UNITS OF INSULIN TO LOWER HER BLOOD GLUCOSE. FURTHER ATTEMPTS TO F/U WITH THE PT WERE UNSUCCESSFUL. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PROD 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 598206

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R INSULIN| INSULIN INFUSION PUMP