BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4093342 · Received September 16, 2014

    Report

    Report Number
    2531779-2014-26411
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    September 4, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED, AND IT WAS EVALUATED BY PRODUCT ANALYSIS ON 10/08/2014 WITH THE FOLLOWING FINDINGS: THE REPORTED EVENT, OF A KEYPAD-RESPONSIVENESS ISSUE, COULD NOT BE ADEQUATELY INVESTIGATED DUE TO THE FAILURE OF THE PUMP TO POWER ON; THUS NO CONCLUSIONS COULD BE DETERMINED IN THIS REGARD. THE RELATION OF THE FOLLOWING DEVICE FAILURES TO THE REPORTED KEYPAD-RESPONSIVENESS ISSUE COULD NOT BE DETERMINED, AS THE REPORTED KEYPAD-RESPONSIVENESS ISSUE WOULD HAVE TO BE DUPLICATED TO DETERMINE THE RELATION OF THESE DEVICE FAILURES: THE KEYPAD COVER WAS REMOVED, AND EVIDENCE OF CONTAMINATION OF WAS FOUND UNDER ALL OF THE KEY CONTACTS. THE PUMP CASE WAS REMOVED, AND CORROSION WAS OBSERVED ON THE KEYPAD FLEX CABLE. THE FOLLOWING DEVICE FAILURES ARE UNRELATED TO THE REPORTED EVENT: THE AUDIO BOLUS BUTTON COVER WAS FOUND TO BE TORN. THE KEYPAD COVER WAS OBSERVED TO BE TORN ACROSS THE OK BUTTON; THIS DEVICE FAILURE IS UNRELATED TO THE REPORTED KEYPAD-RESPONSIVENESS ISSUE, AS IT WAS REPORTED THAT THE DAMAGE OCCURRED SUBSEQUENTLY. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGE PRIOR TO DAMAGE) ISSUE. THE REPORTER ALLEGED THAT THE DOWN ARROW KEYPAD BUTTON WAS UNDER-RESPONSIVE. ALSO, IT WAS REPORTED THAT THE KEYPAD COVER WAS DAMAGED SUBSEQUENT TO THE CHANGE IN RESPONSIVENESS OF THE KEYPAD BUTTON. 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
    571222 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR