BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1982699 · Received February 3, 2011

    Report

    Report Number
    2531779-2011-00637
    Event Type
    Injury
    Date Received
    February 3, 2011
    Date of Event
    December 20, 2010
    Report Date
    January 5, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, AN ANIMAS TERRITORY MANAGER CONTACTED ANIMAS PUMP SUPPORT BECAUSE A DOCTOR CONTACTED HER REGARDING A PATIENT'S RECENT HOSPITALIZATION. THE PATIENT WAS UNABLE TO ACCEPT INCOMING CALLS FROM ANIMAS TO AN EMAIL WAS SENT TO THE PATIENT REQUESTING HIM TO CONTACT ANIMAS PUMP SUPPORT. ON (B)(6) 2011 THE PATIENT CONTACTED ANIMAS PUMP SUPPORT AND PROVIDED THE FOLLOWING INFORMATION: THE PATIENT'S DAUGHTER TOOK HIM TO THE HOSPITAL ON (B)(6) 2010 WHERE HE WAS ADMITTED WITH A LAB BLOOD GLUCOSE RESULT OF 1000 MG/DL. THE PATIENT HAD "LARGE" KETONES AND SLIGHT NAUSEA/VOMITING. THE PATIENT DISCONTINUED USING THE PUMP UPON ADMISSION AND WAS STARTED ON IV INSULIN DRIP. HE CLAIMED THAT 3-4 DAYS PRIOR TO HOSPITALIZATION, HIS BG RANGED FROM 90-270MG/DL AND BUT HIS BG WAS "HI" ON (B)(6) 2010. HE CHANGED THE INSERTION SITE 2 TIMES WHEN HIS BG WAS "HI" AND DID NOT GIVE AN INSULIN INJECTION. THE PATIENT'S BG RESULTS BETWEEN (B)(6) 2010 WERE NOT PROVIDED. THE PATIENT DENIED HAVING ISSUES WITH THE INSERTION SITE AND INFUSION SET BUT DID NOT LOOK FOR AIR BUBBLES OR LEAKING IN THE TUBING CARTRIDGE. THE PATIENT DENIED ANY ILLNESSES AND RECENT CHANGES WITH HIS MEDICATIONS, DIET, AND ACTIVITY LEVELS. THE ANIMAS REPRESENTATIVE WENT THROUGH TROUBLESHOOTING WITH THE PATIENT AND NOTED THE FOLLOWING: THE PUMP SETTINGS WERE REVIEWED AND CONFIRMED TO BE CORRECT AND THE TOTALS IN THE HISTORY ADDED UP CORRECTLY. THE ANIMAS REPRESENTATIVE CONCLUDED THERE WAS NO INDICATION THAT THE PUMP MALFUNCTIONED. THIS COMPLAINT IS STILL BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY WAS HOSPITALIZED FOR ELEVATED BLOOD GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R