BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1131935 · Received August 22, 2008

    Report

    Report Number
    2183996-2008-01279
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 10, 2008
    Report Date
    August 11, 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
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT YESTERDAY MORNING HIS BLOOD GLUCOSE MEASURED "HI" ON HIS BLOOD GLUCOSE MONITOR AND HIS HEART WAS "FLUTTERING." HE STATED THAT HE WAS ALSO VERY THIRSTY AND URINATING FREQUENTLY AND HIS HEAD HURT. HE DISCOVERED THAT HIS INFUSION TUBING HAD BECOME DISCONNECTED AT THE LUER CONNECTION. HE REATTACHED THE INFUSION TUBING AND INJECTED 50 UNITS OF INSULIN TO LOWER HIS BLOOD GLUCOSE. HE STATED THAT THE INFUSION TUBING BECAME DISCONNECTED AGAIN THIS MORNING AND HIS BLOOD GLUCOSE WAS ELEVATED TO 288 MG/DL. HE BOLUSED TO LOWER HIS BLOOD GLUCOSE. HIS NORMAL BLOOD GLUCOSE RANGE IS 120-160 MG/DL. HE STATED THAT ADAPTER HAD BEEN IN USE FOR 8 MONTHS. HE WAS SENT A NEW ADAPTER AND A BATTERY KEY TO USE TO TIGHTEN THE INFUSION TUBING. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PROD WILL 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 594527

    Patients

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