BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2931724 · Received January 28, 2013

    Report

    Report Number
    2531779-2013-01256
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Report Date
    January 26, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEVICE EVALUATION WAS INADVERTENTLY OMITTED FROM THE PREVIOUS REPORT: DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS. 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 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

    FOLLOW-UP #1 DATE OF SUBMISSION 04/10/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT THE KEYPAD WAS PEELING ALONG THE EDGE NEXT TO THE DOWN ARROW BUTTON AND THE SYMBOLS WERE WORN. TESTING CONFIRMED THAT THE OK AND CONTRAST BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND REQUIRED SEVERAL PRESSES TO ELICIT A RESPONSE. THE UP AND DOWN KEYS RESPONDED APPROPRIATELY. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY SCREEN WAS DIM/FADED AND SCRATCHED.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013 REPORTING THAT THE OK BUTTON REQUIRED MULTIPLE PRESSES TO ELICIT A RESPONSE. THE REPORTER DENIED ANY DAMAGE TO THE KEYPAD AND NO KNOWN MOISTURE IN THE PUMP. THE PATIENT REPORTEDLY WORE THE PUMP IN A POCKET AND DID NOT CLEAN THE PUMP. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE KEYPAD RESPONSE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37237 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR