BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2851739 · Received November 29, 2012

    Report

    Report Number
    2531779-2012-14098
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 4, 2012
    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 BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. 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. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE BLACK BOX DOWNLOAD CONFIRMED AN OUT OF BOX FAILURE. THE PUMP HISTORY CONFIRMED PUMP WAS NOT USED FOR DELIVERIES. AN ALARM WAS DUPLICATED DURING INVESTIGATION WHEN THE 1ST REWIND ATTEMPT WAS MADE, ALARM COULD NOT BE CLEARED. THE PUMP COVER WAS REMOVED TO INVESTIGATE; AN OPEN TRACE WAS LOCATED WITHIN THE LINERBOARD FLEX. THE EFFECTED TRACE WAS FOUND TO BE BETWEEN THE MOTOR POWER SUPPLY AND MASTER PROCESSOR.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE REPORTER CONTACTED ANIMAS TO REPORT THE PUMP WOULD NOT POWER ON. THE PATIENT NOTED NO DAMAGE OR CORROSION TO THE PUMP, AND THE PUMP HAD NOT BEEN EXPOSED TO MOISTURE. THE PATIENT REPLACED THE BATTERY AND THE BATTERY CAP TO NO AVAIL. THE BATTERY CAP WAS TIGHT AND SECURE. THE ISSUE WAS NOT RESOLVED. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS 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 15 YR