BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2223714 · Received August 25, 2011

    Report

    Report Number
    2531779-2011-06223
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Report Date
    July 31, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4):DURING INVESTIGATION, THE ALLEGATION THAT THE AUDITORY AND VIBRATORY ALARMS WERE NOT WORKING WAS DUPLICATED. THE PUMP WAS OPENED AND IT THE AUDITORY ALARM CONTACTS WERE FOUND TO BE NOT MAKING PROPER ELECTRICAL CONTACT. THE VIBRATION MOTOR WAS FOUND TO BE MISALIGNED WITH THE MOTOR CONTACTS.

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. 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.

    Description of Event or Problem · 1

    THE PATIENT CLAIMED THAT THE AUDIO AND VIBRATION ALARMS ON THE ANIMAS PUMP IS NOT FUNCTIONING. IN ADDITION, THE PATIENT INDICATED SINCE THE SUBJECT PUMP HAS BEEN REBOOTING, THERE HAS BEEN MORE ELEVATED BLOOD GLUCOSE. REPORTEDLY, HE TOOK 20 UNITS TO CORRECT AN ELEVATED BLOOD GLUCOSE READING OF 457 MG/DL. THE PATIENT DID NOT HAVE ANY SYMPTOMS OF KETONES, NAUSEA, AND VOMITING. THE LAST HIGH BLOOD GLUCOSE THE PATIENT OBTAINED ON (B)(6) 2011, HE TOOK 25 UNITS OF INSULIN VIA THE ANIMAS PUMP. DURING TROUBLESHOOTING, THE ISSUE WAS NOT RESOLVED WITH TRAINING. THE PUMP WILL BE RETURNED FOR INVESTIGATION. THE PATIENT DID NOT REPORT ANY BLOOD GLUCOSE READINGS OR SYMPTOMS THAT MEET ANIMAS CRITERIA FOR A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED AUDIO AND VIBRATION ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR