BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1404898 · Received June 15, 2009

    Report

    Report Number
    2183996-2009-01112
    Event Type
    Injury
    Date Received
    June 15, 2009
    Date of Event
    May 13, 2009
    Report Date
    May 18, 2009
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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

    ON 05/18/2009, THE PT REPORTED THAT IN HER PREVIOUS BOX OF INSULIN INFUSION SETS, SHE HAD 2 SETS THAT DID NOT PROPERLY ADHERE TO HER SKIN AND CAME LOOSE WHILE SHE WAS SLEEPING. SHE SAID, SHE DISCARDED THOSE HEADSETS. SHE STATED THAT INFUSION SETS WERE STORED IN A COOL DRY CLOSET AND NOT EXPOSED TO HEAT OR HUMIDITY. SHE USES ALCOHOL PREP PADS PRIOR TO INSERTING HER HEADSET. SHE THINKS THE LOOSE INFUSION SETS MAY HAVE AFFECTED HER BLOOD GLUCOSE READINGS. SHE STATED THAT OVER THE PAST FEW DAYS, SHE HAS HAD ELEVATED READINGS IN THE 240-320 MG/DL RANGE WITH HER NORMAL RANGE BEING 100-140 MG/DL. SYMPTOMS WERE FATIGUE, THIRST AND FREQUENT URINATION AND SHE TREATED HER READINGS BY BOLUSING INSULIN. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS AVAILABLE TO BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention INSULIN INFUSION PUMP| INSULIN