BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2173918 · Received July 24, 2011

    Report

    Report Number
    2531779-2011-05179
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Report Date
    June 24, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 05/16/2013- DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE BLACK BOX HISTORY WAS OVERWRITTEN FROM THE ORIGINAL DATE OF THE COMPLAINT. THE PUMP WAS IN USE AFTER THE ALLEGED ISSUE. THERE WERE NO UNEXPLAINED POWER ISSUES IN THE HISTORY. DURING TESTING, THE PUMP POWERED ON APPROPRIATELY. THERE WAS NO DAMAGE TO THE BATTERY COMPARTMENT AND THE BATTERY CAP WAS NOT RETURNED. A TEST CAP WAS ATTACHED TO THE PUMP AND THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND. THE COMPLAINT COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE REPORTER CLAIMED THAT THE ANIMAS PUMP DOES NOT TURN ON. THE BATTERY WAS REPLACED TWICE BUT THE POWER ISSUE WAS NOT RESOLVED. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE NOTED THERE WAS NO DAMAGE TO THE BATTERY CAP OR COMPARTMENT. NO SIGN OF CORROSION WAS IN THE BATTERY COMPARTMENT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGED POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR