BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3251661 · Received July 29, 2013

    Report

    Report Number
    2531779-2013-12000
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    June 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 09/19/2013. DEVICE EVALUATION: A RETAIN SAMPLE FROM THE SAME LOT NUMBER WAS TESTED. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST/FORCE TEST/FILL TEST WAS PERFORMED WITH NO FAILURES OBSERVED OR FLUID OBSERVED LEAKING OUT AT THE PLUNGER END OF 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. REVIEW OF THE BLACK BOX REVEALED SEVERAL LOAD STEP MALFUNCTIONS AND MULTIPLE RECORDS OF LOSS OF PRIME. ON TESTING, A REWIND, LOAD AND PRIME SEQUENCE WAS ATTEMPTED; HOWEVER, THE PUMP DID NOT RECOGNIZE THE CARTRIDGE AND EMITTED THE APPROPRIATE ALARM. TWENTY-FOUR HOUR TESTING WAS NOT POSSIBLE DUE TO THE LOAD STEP MALFUNCTION. THE FORCE SENSOR WAS EVALUATED AND FOUND TO BE OUT OF SPECIFICATION. THE PUMP WAS OPENED FOR INVESTIGATION AND REVEALED CORROSION ON THE FORCE SENSOR ASSEMBLY, BATTERY CONNECTION, VIBRATOR MOTOR AND THE BOTTOM OF THE PUMP. HOWEVER, THERE WERE NO VISIBLE SIGNS OF MOISTURE FROM THE PUMP EXTERIOR. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. THE REPORTER STATED THAT THE INSULIN WAS ENTIRELY DISPENSED FROM THE CARTRIDGE DURING THE LOAD 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
    352223 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR