BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3070440 · Received April 22, 2013

    Report

    Report Number
    2531779-2013-04731
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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 03/03/2014-DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/12/2014 WITH THE FOLLOWING FINDINGS:A REVIEW OF THE DEVICE HISTORY INDICATED THAT NO DATA WAS RECORDED FROM THE EVENT DATE, AND NO UNEXPLAINED PUMP REBOOTS WERE OBSERVED IN THE AVAILABLE HISTORY. THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED. NO EVIDENCE OF MOISTURE INGRESS WAS FOUND INSIDE THE BATTERY COMPARTMENT. A BATTERY CAP WAS NOT RETURNED WITH THE PUMP; A TEST CAP WAS USED FOR FURTHER INVESTIGATION. A POWER LOSS WAS NOT OBSERVED. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER INTERRUPTIONS OR RELATED ALARMS. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE INGRESS OR LOOSE COMPONENTS WAS FOUND. NO EVIDENCE OF INTERMITTENT CONTACT WAS FOUND ON THE BATTERY TERMINAL CONTACTS. UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN APPEARED DIM AND DISCOLORED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (NO POWER) ISSUE. THE PUMP REPORTEDLY LOST POWER SEVERAL TIMES WITHOUT USER INTERVENTION. 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
    171209 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR