BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2851716 · Received November 29, 2012

    Report

    Report Number
    2531779-2012-14095
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 3, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. 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. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWS NO EVIDENCE OF A LOAD STEP MALFUNCTION. THE PUMP POWERS ON NORMALLY. AN EZPRIME OPERATION WAS SUCCESSFULLY PERFORMED AND THE PUMP WAS ABLE TO PRIME NORMALLY. FORCE SENSOR READINGS WERE FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP WAS OPENED AND THERE WAS NO DAMAGE FOUND TO THE FORCE SENSOR CIRCUIT OR TO THE POWER CIRCUIT. THERE WAS NO DEFECT FOUND ON INVESTIGATION. THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE REPORTER CONTACTED ANIMAS TO REPORT AN ISSUE DURING THE LOAD STEP IN WHICH THE PUMP PUSHED SEVERAL DROPS OF INSULIN OUT OF THE FILLED CARTRIDGE. THE PATIENT CONFIRMED THE PUMP HAD NOT BEEN EXPOSED TO TRAUMA OR MOISTURE. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS ISSUE.

    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 5 YR