BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2854361 · Received December 3, 2012

    Report

    Report Number
    2531779-2012-14140
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Report Date
    September 3, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE BLACK BOX REVEALED MULTIPLE REPLACE BATTERY, LOW BATTERY WARNINGS AND POWER ON RESETS. THE BATTERY COMPARTMENT WAS FOUND TO BE INTACT AND THERE WERE NO CRACKS. THE RETURNED BATTERY FULLY TIGHTENED AND THE YELLOW O-RING WAS NOT VISIBLE. THERE WAS NO EVIDENCE OF MOISTURE INSIDE BATTERY COMPARTMENT. THE CURRENT DRAWS ARE ALL WITHIN SPECIFICATIONS. THE POWER LOSS WAS DUPLICATED. THE PUMP CASE WAS REMOVED AND AND INTERMITTENT SOLDER CONNECTIONS ON BOTH POSITIVE AND NEGATIVE BATTERY TERMINALS. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS.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. (B)(4).

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THE ALERT DATE AND DATE OF THIS REPORT IS 11/06/2012 NOT 09/03/2012 AS PREVIOUSLY REPORTED.

    Description of Event or Problem · 1

    THE PUMP WAS RETURNED FOR INVESTIGATION. INVESTIGATION REVEALED THAT THERE WAS INTERMITTENT SOLDER CONNECTIONS ON BOTH POSITIVE AND NEGATIVE BATTERY TERMINALS. THIS REPORT IS MADE BASED ON RESULTS OF INVESTIGATION COMPLETED ON (B)(6) 2012

    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 45 YR