BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1063137 · Received June 20, 2008

    Report

    Report Number
    2183996-2008-00907
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 3, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 THAT THE PREVIOUS DAY HER BLOOD GLUCOSE ELEVATED TO 300 MG/DL. HER NORMAL BLOOD GLUCOSE RANGE IS BELOW 200 MG/DL. SHE STATED THAT SHE BOLUSED TO LOWER HER BLOOD GLUCOSE BUT HER READINGS REMAINED ELEVATED. SHE THEN FOUND THAT HER INFUSION TUBING WAS FULL OF AIR. SHE INJECTED INSULIN TO LOWER HER BLOOD GLUCOSE AND SHE CHANGED THE INSULIN CARTRIDGE AND INFUSION TUBING. SHE STATED THAT SHE PRIMED THE INFUSION TUBING BUT THERE WAS STILL AIR PRESENT. SHE STATED THAT THE LUER CONNECTION WAS A LITTLE LOOSE AND SHE TIGHTENED IT AND PRIMED AGAIN. SHE WAS ABLE TO REMOVE THE AIR. SHE STATED THAT SHE DID NOT ALLOW THE INSULIN TO REACH ROOM TEMPERATURE BEFORE USE. SHE WAS ADVISED TO ALWAYS USE ROOM TEMPERATURE INSULIN. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. 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 FPA DISETRONIC MEDICAL SYSTEMS NA UNK

    Patients

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