BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3211783 · Received July 8, 2013

    Report

    Report Number
    2531779-2013-09873
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Report Date
    June 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/25/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP POWERED ON AND DISPLAYED THE ¿VERIFY¿ SCREEN. THE PUMP HISTORY SHOWED LOSS OF PRIME DUE TO ZERO FORCE WARNINGS. THE PUMP PASSED ¿EZ-PRIME¿ STEPS AND WAS ABLE TO LOAD AND PRIME A FULL CARTRIDGE CORRECTLY. DURING TESTING, THE FORCE SENSOR CALIBRATION WAS FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP¿S COVER WAS REMOVED AND AN INTERMITTENT CONNECTION WAS FOUND TO THE FORCE SENSOR FLEX PINS DUE A CRACKED SOLDER JOINT AROUND THE PIN.

    Additional Manufacturer Narrative · 1

    A RESERVED SAMPLE FROM THE SAME CARTRIDGE LOT NUMBER WAS TESTED AND EVALUATED BY PRODUCT ANALYSIS ON 08/07/2013 WITH THE FOLLOWING FINDINGS: NO DEFECT FOUND WITH RETAINED PRODUCT. THE COMPLAINT COULD NOT BE DUPLICATED DURING INVESTIGATION. A LEAK TEST WAS PERFORMED WITH NO FAILURES BEING OBSERVED; NO LEAKS WERE OBSERVED FROM THE LUER CONNECTION, O-RINGS, OR ANYWHERE ELSE IN THE CARTRIDGE. EACH CARTRIDGE LOT IS SUBJECTED TO A STATISTICAL SAMPLING PLAN AND MUST PASS TESTING FOR FORCE (OCCLUSION AND LOSS OF PRIME), CRACKS, AND FOREIGN MATERIAL PRIOR TO RELEASE FOR DISTRIBUTION.

    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 PRIME (LOAD STEP MALFUNCTION) ISSUE. THE REPORTER STATED THE PUMP DISPENSED THE ENTIRE CARTRIDGE OF INSULIN DURING THE LOAD CARTRIDGE STEP. 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
    311240 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR