BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2240234 · Received September 9, 2011

    Report

    Report Number
    2531779-2011-06662
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE BATTERY WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. VISUAL INSPECTION REVEALED THAT THE BATTERY COMPARTMENT IS CRACKED. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF THE PUMP. THERE WAS EVIDENCE OF CORROSION OBSERVED IN THE BATTERY COMPARTMENT. EVALUATION FOUND THAT THE PUMP POWERS UP PROPERLY AND THE POWER CIRCUIT DOES NOT DRAW EXCESSIVE CURRENT. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO EVIDENCE OF OVERHEATING. THERE WAS NO DAMAGE FOUND TO THE POWER CIRCUIT. THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED DURING TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PUMP WAS HOT TO THE TOUCH AFTER THE PATIENT WENT SWIMMING. THE PATIENT NOTED A BLACK CORROSION LIQUID ON THE BATTERY; THERE WAS NO DAMAGE TO THE BATTERY CAP OR COMPARTMENT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION OTP GLUCOSE MGMT SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR