BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2241850 · Received September 9, 2011

    Report

    Report Number
    2531779-2011-06689
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Report Date
    August 14, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED CONTAMINATION IN THE FORCE SENSOR ASSEMBLY AND AN OUT OF CALIBRATION FORCE SENSOR. DURING TESTING, THE PUMP LOAD STEP DID NOT DETECT THE FILLED CARTRIDGE. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED AND CORROSION WAS OBSERVED INSIDE. THE USER GUIDE INSTRUCTS THE PATIENT THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP. THE DISPLAY SCREEN WAS FOUND TO BE DIM WITH A RED TINT. THE UP AND OK BUTTONS WERE FOUND TO BE INTERMITTENTLY RESPONDING TO PRESSES. THE KEYPAD WAS REMOVED AND ADHESIVE WAS OBSERVED UNDER THE BUTTON CONTACTS.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME. 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. CORRECTION NUMBER: 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT DURING THE LOAD CARTRIDGE STEP, INSULIN WAS PUSHED OUT OF THE CARTRIDGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR