BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3103370 · Received May 9, 2013

    Report

    Report Number
    2531779-2013-06123
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Report Date
    April 16, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: POWER ON RESETS OBSERVED IN THE BLACK BOX. NO CRACKS IN THE BATTERY COMPARTMENT. NO DAMAGE FOUND TO THE RETURNED BATTERY CAP. RETURNED BATTERY CAP TIGHTENS TO THE PUMP UNTIL RESISTANCE IS MET AND NO YELLOW O RING IS VISIBLE. A 24 HOUR DURATION TEST WAS PERFORMED USING THE RETURNED BATTERY CAP; PUMP WAS STILL DELIVERING AT CONCLUSION OF TEST; NO POWER LOSS EVENTS WERE DUPLICATED USING THE RETURNED BATTERY CAP. THE RETURNED BATTERY CAP WIDTH AND HEIGHT MEASUREMENTS ARE ALL WITHIN SPECIFIED RANGE. A PINKISH CONTRAST WAS OBSERVED ON THE DISPLAY SCREEN. REMOVED THE PUMP COVER AND REPLACED PINK DISPLAY WITH TEST DISPLAY. THE TEST DISPLAY HAS NORMAL CONTRAST WITH NO VISIBLE SIGNS OF DISCOLORATION. THERE WAS NO EVIDENCE OF INTERMITTENT CONNECTIONS OR MOISTURE CONTAMINATION IDENTIFIED INSIDE PUMP. A TEAR IN THE KEYPAD NEAR THE UP AND DOWN KEY WAS OBSERVED. ALL KEYS RESPONDED APPROPRIATELY. THE POWER COMPLIANT WAS VERIFIED IN THE BLACK BOX BUT COULD NOT BE DUPLICATED DURING THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. IT WAS REPORTED THAT THE PUMP LOST POWER WITHOUT USER INTERVENTION. 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
    204332 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR