BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3050695 · Received April 10, 2013

    Report

    Report Number
    2531779-2013-03980
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 17, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 06/25/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP¿S HISTORY SHOWED DATES FROM (B)(6) 2013 WITH ONE LOW BATTERY WARNING AND MULTIPLE REPLACE BATTERY ALARMS. THE HISTORY SHOWED EVIDENCE OF PARTIALLY DISCHARGED BATTERIES BEING INSTALLED IN THE PUMP ON (B)(6) 2013. DURING EVALUATION, THE BATTERY COMPARTMENT WAS FOUND TO BE INTACT AND NO MOISTURE WAS FOUND IN THE COMPARTMENT. THE BATTERY CAP WAS ABLE TO FULLY TIGHTEN ON AND THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER LOSS OR POWER RELATED WARNINGS OR ALARMS. THE CURRENT DRAWS WERE FOUND TO BE WITHIN SPECIFICATIONS. THE COMPLAINT COULD NOT BE DUPLICATED DURING TESTING.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (POWER ISSUE) ISSUE. THE REPORTER ATTEMPTED TO POWER THE PUMP ON WITH MULTIPLE BATTERIES AND NEW BATTERY CAP BUT CONTINUED TO RECEIVE "REPLACE BATTERY" ALARMS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148207 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR