BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2840023 · Received November 20, 2012

    Report

    Report Number
    2531779-2012-13795
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Report Date
    October 23, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4): REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY REVEALED A 'LOAD STEP MALFUNCTION' RECORDED ON (B)(4) 2012. ON TESTING, THE PUMP POWERED ON NORMALLY AND SUCCESSFULLY PERFORMED AN EZ-PRIME FUNCTION. THE FORCE SENSOR WAS TESTED AND FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED A CRACK AT THE FORCE SENSOR FLEX NEAR THE SOLDER JOINT OF THE PINS.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 REPORTING THAT THE PUMP WAS NOT READING THE CARTRIDGE CORRECTLY DURING THE LOAD STEP. THE PATIENT STATED THAT A CARTRIDGE WITH 200 UNITS WAS PLACED IN THE PUMP AND AFTER THE PUMP LOAD STEP THE PUMP INDICATED 143 UNITS. THE PATIENT REPORTED TRYING TO PERFORM THE LOAD STEP MULTIPLE TIMES WITH THE SAME CARTRIDGE AND THE PUMP STOPPED AT 176, 178, 149 UNITS. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE PUMP LOAD STEP MALFUNCTION.

    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 69 YR