BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2991625 · Received March 6, 2013

    Report

    Report Number
    2531779-2013-02446
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 20, 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

    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 04/25/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE KEYPAD WAS FOUND TO BE FULLY INTACT; NO PEELING OR DAMAGE WAS OBSERVED. DURING TESTING, THE UP ARROW AND CONTRAST KEYPAD BUTTONS WERE INTERMITTENTLY UNRESPONSIVE AND REQUIRED MULTIPLE PRESSES WITH INCREASED FORCE TO ELICIT A RESPONSE; THE DOWN ARROW AND OK KEYPAD BUTTONS RESPONDED APPROPRIATELY. THE SYMBOLS WERE WORN OFF THE UP ARROW, OK, AND CONTRAST BUTTONS. DURING INVESTIGATION, EVIDENCE OF CONTAMINATION WAS FOUND UNDER ALL KEY CONTACTS. ADDITIONALLY, THE AUDIO BOLUS BUTTON WAS UNRESPONSIVE, AND THE INTERNAL PLUG WAS MISALIGNED. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED A CRACKED BATTERY COMPARTMENT. THERE WAS NO EVIDENCE OF MOISTURE IN THE BATTERY COMPARTMENT OR ISSUE WITH POWER LOSS.

    Description of Event or Problem · 1

    ON (B)(4) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. IT WAS REPORTED THAT THE DOWN ARROW AND OK KEYPAD BUTTONS REQUIRED HARD PRESSES TO ELICIT A RESPONSE. 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
    94839 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR