BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4092915 · Received September 16, 2014

    Report

    Report Number
    2531779-2014-26373
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 12/01/2014 WITH THE FOLLOWING FINDINGS:THERE WAS NO EVIDENCE OF SHORT BATTERY LIFE OR EXCESSIVE BATTERY USAGE OBSERVED IN THE BLACK BOX DATA. EVALUATION REVEALED THAT THE PUMP DREW ELECTRIC CURRENT AT LEVELS WITHIN THE SPECIFICATIONS: THE REPORTED BATTERY-LIFE ISSUE WAS NOT DUPLICATED. THE PUMP CASE WAS REMOVED, AND NO EVIDENCE OF INTERNAL DAMAGE OR DEFECT WAS FOUND. UNRELATED TO THE REPORTED ISSUE, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED FROM THE GRIP PAD TO THE CASE SEAL. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1; DATE OF SUBMISSION: 10/09/2014.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Description of Event or Problem · 1

    THE REPORTER ALLEGED THAT THE BATTERY LIFE ICON DISPLAYED ON THE USER INTERFACE WAS INACCURATE, AS IT DISPLAYED INCONSISTENT VALUES AT THE TIME OF SEPARATE OCCURRENCES OF A LOW BATTERY WARNING. THE ALLEGED ISSUE IS NOT LIKELY TO CAUSE AN ADVERSE EVENT, BY MEANS OF INTERFERING WITH INSULIN DELIVERY OR OTHERWISE.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE) ISSUE. THE REPORTER ALLEGED THAT BATTERY LIFE WAS SHORTER THAN EXPECTED. CUSTOMER SUPPORT HAS MADE SEVERAL ATTEMPTS TO CONTACT THE CONSUMER TO ACQUIRE ADDITIONAL INFORMATION. THERE IS NO FURTHER INFORMATION REGARDING THE COMPLAINT AVAILABLE AT THIS TIME; IF FURTHER INFORMATION IS PROVIDED, A FOLLOW UP REPORT SHALL BE MADE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED 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
    573591 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR