BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2213278 · Received August 16, 2011

    Report

    Report Number
    2531779-2011-05944
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    December 3, 2009
    Report Date
    January 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS AND REPORTED THAT SHE WAS HOSPITALIZED FROM (B)(6) 2009 TO (B)(6) 2009 FOR DKA. THE PATIENT CLAIMED THAT SHE HAD CHANGED HER SITE ON (B)(6) 2009 AND HER BLOOD GLUCOSE (BG) WAS OK ALL DAY. THE PATIENT REPORTEDLY WOKE UP AT 3:00 AM THAT MORNING WITH A BG LEVEL OF "220 MG/DL." THE PATIENT CLAIMED THAT SHE TOOK A CORRECTION BOLUS AT THAT TIME AND THEN WENT BACK TO SLEEP. BY 6:00 AM WHEN THE PATIENT WOKE UP, SHE INDICATED THAT HER BG LEVEL WAS "350 MG/DL." THE PATIENT DISCONNECTED AND PRIMED THE PUMP WITHOUT ANY PROBLEMS AT THAT TIME. SHE RECONNECTED AND DELIVERED A CORRECTION BOLUS AT AN UNSPECIFIED TIME. WHILE GETTING READY FOR WORK, THE PATIENT REPORTEDLY BEGAN TO FEEL SICK WITH SYMPTOMS OF CHEST PAIN, SHORTNESS OF BREATH, AND VOMITING. THE PATIENT CLAIMED THAT SHE FOUND KETONES IN HER URINE. THE PATIENT REPORTEDLY CALLED HER DOCTOR, TOOK AN INJECTION OF INSULIN, AND THEN WENT TO AN EMERGENCY ROOM (ER). UPON ARRIVING AT THE ER, THE PATIENT'S BG LEVEL WAS OVER "500 MG/DL." THE PATIENT WAS REMOVED FROM THE PUMP AND AN INSULIN DRIP WAS ADMINISTERED. THE PATIENT DENIED THAT THERE WAS LEAKING OF INSULIN AT THE SITE OR ELSEWHERE. SHE ALSO DENIED THAT THERE WERE ANY ALARMS FROM THE PUMP. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE WAS HOSPITALIZED FOR DKA. HOWEVER, IT IS UNKNOWN AT THIS TIME IF THE DEVICE CONTRIBUTED IN ANY WAY TO THE PATIENT'S INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 1250 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 30 Hospitalization| L| R