BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2931744 · Received January 28, 2013

    Report

    Report Number
    2531779-2013-01259
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 18, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP BLACK BOX SHOWED THAT POWER ON RESETS HAD OCCURRED. THE PUMP CASING WAS OBSERVED TO BE CRACKED AT THE BATTERY COMPARTMENT. THE BATTERY CAP RETURNED WITH THE PUMP WAS FOUND TO HAVE STRIPPED THREADS. THE BATTERY CAP WAS UNABLE TO MAINTAIN AND ELECTRICAL CONNECTION WHEN ATTACHED TO THE PUMP. A TEST CAP WAS INSERTED AND THE PUMP POWERED ON APPROPRIATELY. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT POWER ISSUES. THE PUMP WAS OPENED AND NO INTERNAL DEFECTS WERE FOUND. THE USER GUIDE INSTRUCTS THE PATIENT TO REPLACE THE BATTERY CAP AT LEAST ONCE PER YEAR AND THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(4) 2013 REPORTING THAT THE PUMP HAD INTERMITTENT POWER. THE PATIENT CONFIRMED THAT THE BATTERY CAP WAS SECURED APPROPRIATELY WITHOUT ANY YELLOW O-RING VISIBLE. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE PUMP POWER ISSUE WHICH WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36903 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR