BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3112413 · Received May 14, 2013

    Report

    Report Number
    2531779-2013-06402
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Report Date
    April 23, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 06/20/2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT MOISTURE CORROSION WAS OBSERVED IN THE PUMP ON THE DISPLAY SCREEN. THE PUMP CASE IS CRACKED BETWEEN THE DISPLAY LENS AND THE CASE SEAL, THE CASE SEAL LEAK IS CONCLUDED. THE KEYPAD RUBBER IS UNDAMAGED; PUMP POWERS UP WITH A HARD ALARM UNABLE TO CLEAR, UNABLE TO VERIFY KEYPAD¿S BUTTONS RESPONSE AND TO TAKE AUDIBLE TEST READING. THE KEYPAD WAS REMOVED FROM THE BASE, CONTAMINATION WAS OBSERVED TO ALL KEY¿S CONTACTS. PUMP WAS OPENED, MOISTURE CORROSION WAS OBSERVED TO THE KEYPAD FLEX/CONNECTOR.

    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

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A BUTTON/KEYPAD (TACTILE CHANGES/UNRESPONSIVE) ISSUE. THE REPORTER STATED THAT THE KEYPAD BUTTONS WERE UNRESPONSIVE. THE REPORTER MENTIONED THAT THE PUMP WAS EXPOSED TO WATER THE PREVIOUS DAY AND EXHIBITED SIGNS OF WATER INGRESS AND CONDENSATION BEHIND THE DISPLAY LENS. 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
    211862 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR