BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3191322 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09056
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    May 31, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 08/16/2013 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/25/2013 WITH THE FOLLOWING FINDINGS:THE KEYPAD WAS FOUND TO BE PEELING/LIFTING FROM BELOW THE OK BUTTON AND EXTENDED ALONG THE LEFT SIDE OF THE COVER. DURING TESTING, ALL KEYPAD BUTTONS WERE FOUND TO BE INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE BUTTON PRESSES WITH INCREASED FORCE TO ELICIT A RESPONSE. THERE WAS EVIDENCE OF CONTAMINATION FOUND UNDER ALL KEY CONTACTS. 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

    THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ON (B)(6) 2013 THE REPORTER CONTACTED ANIMAS TO REPORT THE KEYPAD BUTTONS HAD TO BE PRESSED MULTIPLE TIMES IN ORDER TO ACTIVATE THE DESIRED PUMP FUNCTIONS. THE PATIENT NOTED THE KEYPAD WAS INTACT. THE ISSUE WAS NOT RESOLVED. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE. 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
    289833 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR