BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2991220 · Received March 6, 2013

    Report

    Report Number
    2531779-2013-02420
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 05/07/2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY REVEALED A POWER ON RESET ON (B)(4) 2013. NO DAMAGE WAS FOUND TO THE RETURNED BATTERY CAP; THE BATTERY CAP SECURED TIGHTLY TO THE PUMP AND MAINTAINED ELECTRICAL CONNECTION. NO DAMAGE WAS FOUND TO THE BATTERY COMPARTMENT. THE BATTERY CAP CONTACT WAS FOUND TO BE WITHIN SPECIFICATION. THE PUMP POWERED ON WITH NO ISSUES AND THE "EZ-PRIME" STEPS WERE SUCCESSFULLY PERFORMED. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO RE-BOOTING ISSUES. THE PUMP WAS OPENED; NO MOISTURE INGRESS WAS OBSERVED INSIDE THE UNIT. NO INTERMITTENT CONDITIONS OR DEFECTS WERE FOUND WITH THE FLEXES OR THE PCB.

    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 (INTERMITTENT POWER) ISSUE. REPORTEDLY, THE PUMP WAS FOUND ON THE VERIFY SCREEN. 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
    96271 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR