BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242726 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11721
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    July 1, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    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: DATE OF SUBMISSION 10/09/2013. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/18/2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, A REVIEW OF THE PUMP¿S HISTORY SHOWED NO RECORD OF A POWER ISSUE. THE BLACK BOX DID RECORD MULTIPLE LOW NON-ZERO FORCE LOSS OF PRIMES. BASED ON LOSS OF PRIMES MENTIONED IN THE COMPLAINT, THE FORCE SENSOR AND 10 UNIT BOLUS TESTS WERE PERFORMED. THE PUMP REWIND, LOAD, AND PRIME STEPS WERE PERFORMED WITH NO LOSS OF POWER OR PRIME. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL PROGRAM WITH NO LOSS OF POWER OR PRIME. THE BATTERY CAP WAS ABLE TO FULLY TIGHTEN TO THE PUMP. THE THREADS ON BOTH THE BATTERY COMPARTMENT AND CAP WERE INTACT AND NO CORROSION OR CRACKS WERE OBSERVED. THE BATTERY CAP HEIGHT AND WIDTH MEASUREMENTS WERE WITHIN SPECIFICATIONS. THE FORCE SENSOR CALIBRATION WAS FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP WAS OPENED AND NO DEFECTS WERE FOUND TO THE POWER AND FORCE SENSOR CIRCUITS. THE INTERMITTENT POWER ISSUE WAS NOT ABLE TO BE DUPLICATED. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE; THE VERIFY SCREEN WILL RANDOMLY APPEAR. 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
    342392 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR