BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUP

    MDR report key: 1933800 · Received December 13, 2010

    Report

    Report Number
    2531779-2010-02856
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT BEING RETURNED AT THIS TIME TO ANIMAS FOR EVAL.

    Description of Event or Problem · 1

    THE PT CONTACTED ANIMAS ON (B)(6), 2010, ALLEGING THAT SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE AND DKA (DIABETIC KETOACIDOSIS). TWO DAYS PRIOR TO CONTACTING ANIMAS ON (B)(6), 2010, THE PT CLAIMED THAT HER BLOOD GLUCOSE LEVELS BECAME HIGH AND WERE OVER 300 MG/DL. THE PT DENIED THAT SHE HAD ANY KETONES OR SYMPTOMS. SHE ALSO DENIED THAT HER BLOOD GLUCOSE DID NOT RESPOND TO SYRINGE INJECTION. THE PT ALSO CLAIMED THAT SHE HAD CHANGED HER SITE 4 TIMES ON (B)(6), 2010, BUT HER BLOOD GLUCOSE LEVELS HAD REMAINED AROUND 300-350 MG/DL. THE PT DENIED ANY NEW MEDICATIONS/ILLNESSES. A REVIEW OF THE PUMP'S HISTORY REVEALED THAT THE TDD HISTORY WAS CORRECT. THROUGH TROUBLESHOOTING, THE PATENT TRIED TO GIVE A 5 UNIT AND A 10 UNIT AIR BOLUS. THE PT CLAIMED THAT NOTHING DRIPPED OUT. THE PT STATED THAT POSSIBLY THERE WERE AIR BUBBLES IN THE TUBING/CARTRIDGE. THE PT DID NOT HAVE ADD'L SUPPLIES FOR TROUBLESHOOTING. AT THE TIME OF THE HOSPITALIZATION AND CONTACT WITH THE ANIMAS REP, THE PT WAS REPORTEDLY ON AN INSULIN DRIP AND HER BLOOD GLUCOSE LEVEL WAS AT 302 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| L| R