BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2994024 · Received March 8, 2013

    Report

    Report Number
    2531779-2013-02495
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Report Date
    February 27, 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

    FOLLOW-UP #1 DATE OF SUBMISSION 05/28/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: BLACK BOX REVIEW REVEALS NO ACTIVITY OUTSIDE NORMAL USE OBSERVED. ACCORDING THE BLACK BOX, A 0U BASAL PROGRAM WAS ACTIVE FOR 9 MINUTES. THE TOTAL DAILY DOSE ADDED UP CORRECTLY AND REVEAL THE USER'S PROGRAMMED BASAL RATES TARGET. THE PUMP POWERS UP AND PAIRS WITH A TEST METER SUCCESSFULLY. THE UNIT WAS EXERCISED FOR 24 HOURS, NO ALARMS OCCURRED DURING TESTING. HISTORY RECORDED ACCURATELY BOLUSES INFO ON THE CORRECT TIME AND ORDER. OPENED THE PUMP, NO DAMAGE WAS FOUND TO THE FORCE SENSOR CIRCUIT OR ON THE POWER CIRCUIT. NO MOISTURE INGRESS FOUND INSIDE THE PCB. THERE WAS NO DEFECT FOUND.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE PUMP LOST PRIME MULTIPLE TIMES ON (B)(6) 2013. DURING A REVIEW OF THE PUMP HISTORY, THERE WERE SEVERAL ZERO UNIT BASAL ENTRIES. THE REVIEW FOUND THAT ONE OF THE ZERO UNIT ENTRIES WAS RELATED TO A SITE CHANGE, ANOTHER WAS RELATED TO THE PATIENT PERFORMING ONE OF THE EZPRIME FUNCTIONS, BUT ONE ZERO UNIT BASAL ENTRY FROM 10:37 AM WAS UNEXPLAINED BY THE PUMP HISTORY. THIS REPORT IS MADE BASED ON THE ALLEGATION OF AN UNEXPLAINED ZERO UNIT BASAL RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99565 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR