BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3001978 · Received March 13, 2013

    Report

    Report Number
    2531779-2013-02663
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Report Date
    February 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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 04/19/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY REVEALED REBOOTS. NO DAMAGE WAS FOUND TO THE BATTERY COMPARTMENT OR BATTERY CAP. THE BATTERY CAP WAS FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS OR POWER ISSUES OCCURRING. THE PUMP COVER WAS REMOVED AND NO DAMAGE, EVIDENCE OF MOISTURE, OR INTERMITTENT CONNECTION WAS FOUND IN THE POWER CIRCUIT OR BATTERY FLEX. UNRELATED TO THE COMPLAINT, THE PUMP'S HISTORY SHOWED A TIME AND DATE RESET TO FACTORY DEFAULT. THE PUMP'S INTERNAL BATTERY WAS FOUND LEAKING.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP WAS TURNING OFF AND ON. THE REPORTER CONFIRMED THAT THE BATTERY CAP WAS SECURE TO THE PUMP WITH NO DAMAGE TO THE BATTERY COMPARTMENT OR PUMP. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE PUMP POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105164 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR