BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2122249 · Received June 13, 2011

    Report

    Report Number
    2531779-2011-04091
    Event Type
    Malfunction
    Date Received
    June 13, 2011
    Report Date
    May 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION. THE EVALUATION OF THE PRODUCT HAS NOT BEEN COMPLETED; THEREFORE, NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. THE REPORT IS 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)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: EVALUATION FOUND THAT THE PUMP POWERS UP PROPERLY AND THE POWER CIRCUIT DOES NOT DRAW EXCESSIVE CURRENT. A REVIEW OF THE PUMP HISTORY INDICATED THAT REBOOTING HAD OCCURRED WHICH COULD NOT BE DUPLICATED DURING TESTING. THE PUMP HISTORY INDICATED THAT THE REBOOTING WAS PRECEDED BY A "REPLACE BATTERY" ALARM ON (B)(6) 2011. A "REPLACE BATTERY" ALARM WAS REPRODUCED DURING TESTING, AND THE PUMP EMITTED THE APPROPRIATE AUDIBLE AND VISUAL ALERTS. THERE WAS NO DAMAGE FOUND TO THE BATTERY COMPARTMENT, BATTERY CAP CONNECTIONS, OR TO THE POWER CIRCUIT. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OR POWER ISSUES OCCURRING. 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

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED ANIMAS ALLEGING THAT THE PUMP WOULD NOT POWER ON. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT CLAIMED THAT HE DEVELOPED A BLOOD GLUCOSE (BG) LEVEL OF "400 MG/DL" AND FELT LIKE "CRAP." BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT THE PUMP WOULD NOT POWER ON. THERE IS NO EVIDENCE, HOWEVER, THAT THE ALLEGED ISSUE CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S REPORTED BG READING AND SYMPTOM DO NOT MEET ANIMAS' CRITERIA FOR A SERIOUS 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 23 YR