BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3043538 · Received April 9, 2013

    Report

    Report Number
    2531779-2013-03855
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Report Date
    March 14, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 06/25/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/29/2013 WITH THE FOLLOWING FINDINGS: THE PUMP¿S HISTORY SHOWED NO EVIDENCE OF REBOOTS. DURING EVALUATION, NO DAMAGE WAS OBSERVED TO THE PUMP¿S BATTERY COMPARTMENT. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP, AND A TEST CAP SECURED ON TIGHTLY WITH NO ISSUES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH A 1 UNIT PER HOUR BASAL PROGRAM, NO POWER INTERRUPTIONS, ERRORS, ALARMS, OR WARNINGS OCCURRED. THE PUMP COVER WAS REMOVED AND NO INTERNAL MOISTURE OR DAMAGE WAS FOUND TO THE POWER CIRCUIT OR BATTERY FLEX.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. THE REPORTER INDICATED THAT ON ONE OCCASION THE PUMP SCREEN LIT UP WITHOUT USER PRESSES AND THEN THE PUMP WENT DEAD WITH NO AUDIO TONES OR VIBRATION AND A BLANK SCREEN. THE REPORTER CONFIRMED NO POWER LOSS ISSUES SINCE THE INITIAL EVENT. 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
    146810 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR