BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3252847 · Received July 29, 2013

    Report

    Report Number
    2531779-2013-12025
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/07/2013 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/16/2013 WITH THE FOLLOWING FINDINGS: THE ¿LOW BATTERY¿ WARNING AND ¿REPLACE BATTERY¿ ALARM WAS NOTED IN THE BLACK BOX ON 06/30/2013. A ¿LOW BATTERY¿ WARNING AND A ¿REPLACE BATTERY¿ ALARMS WERE REPRODUCED FOR THE INVESTIGATION. BOTH OCCURRED AT THE CORRECT VOLTAGE. BOTH RECORDED IT THE CORRECT ORDER. A 10UNIT AUDIO AND 10UNIT NORMAL BOLUS WAS SUCCESSFULLY PERFORMED ON THE PUMP. BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. NO ALARMS OCCURRED DURING TESTING. THE REPORTED COMPLAINT WAS UNABLE TO BE DUPLICATED DURING TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS ISSUE. REPORTEDLY, THE PUMP EMITTED A LOW BATTERY ALARM AND REPLACE BATTERY ALARM AT THE SAME TIME AT 7:22 ON (B)(6) 2013. THE PUMP AGAIN ALARMED FOR LOW BATTERY SEVERAL HOURS LATER. 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
    353679 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR