BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2082457 · Received May 10, 2011

    Report

    Report Number
    2531779-2011-03259
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Report Date
    April 13, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED AN EVALUATION WILL BE CONDUCTED AND THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(4) 2011-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT LOSS OF PRIME WARNINGS ASSOCIATED WITH HIGH FORCE HAD OCCURRED WHICH COULD NOT BE DUPLICATED DURING TESTING. THERE WERE NO INDICATIONS THAT THE CARTRIDGE WAS NOT DETECTED DURING THE LOAD STEP IN THE PUMP HISTORY, AND THE PISTON ACCURATELY DETECTED THE CARTRIDGE DURING TESTING. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO MOTOR MALFUNCTIONS. A REVIEW OF THE DEVICE HISTORY RECORD INDICATED THAT THE PUMP WAS OPERATING WITHIN SPECIFICATIONS AT THE TIME OF RELEASE. 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

    THE PUMP REPORTEDLY STOPS DELIVERING INSULIN WHEN THE CARTRIDGE IS HALF FULL. IT REPORTEDLY IS NOT DUE TO ANY OCCLUSION. THE ISSUE ALLEGEDLY STARTED 3 WEEKS PRIOR TO BEING REPORTED. THE PATIENT REPORTEDLY CHANGED THE BATTERY AND USED DIFFERENT CARTRIDGES WITH DIFFERENT LOT NUMBERS IN THE PUMP AND THE ISSUE PERSISTED. THE PATIENT SAID THAT THERE WAS NO ALARM TO ALERT OF THE DELIVERY STOPPING. HE SAID BECAME AWARE OF THE DELIVERY ISSUE WHEN HE NOTICED HIS BLOOD GLUCOSE LEVELS INCREASING. HE DID NOT MENTION ANY SYMPTOMS OR INJURY.

    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