BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2935716 · Received January 30, 2013

    Report

    Report Number
    2531779-2013-01374
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Report Date
    January 10, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 03/11/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWS NO ACTIVITY OUTSIDE NORMAL USE. SEVERAL "REPLACE BATTERY" ALARMS WERE OBSERVED DUE NORMAL DISCHARGED BATTERY WEAR. THE BATTERY WAS NOT RETURNED WITH THE PUMP FOR INVESTIGATION. VISUAL INSPECTION REVEALED THE BATTERY CAP THREADS ARE STRIPPED. THE BATTERY CAP WAS UNABLE TO MAINTAIN AN ELECTRICAL CONNECTION. A TEST BATTERY CAP WAS USED TO COMPLETE INVESTIGATION. THE PUMP POWERS ON NORMALLY AND WAS EXERCISED FOR 24 HOURS WITH NO ALARMS AND NO TEMPERATURE ISSUES OCCURRING. THE PUMP ELECTRICAL DRAWS WERE FOUND TO BE WITHIN SPECIFICATION. NO DEFECTS WERE FOUND TO THE POWER CIRCUIT OR THE POWER FLEX. THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED ON INVESTIGATION. A DAMAGED BATTERY CAP IS GENERALLY OBVIOUS AND DETECTABLE BY THE USER. THEREFORE THE DETECTABLE FLAW MAY PREVENT THE USER FROM CONTINUING USE OF THE DEVICE OR CAUSE A CONDITION THAT MAKES CONTINUED USE OF THE DEVICE IMPOSSIBLE. THE OWNER¿S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A TEMPERATURE (TEMP - NO PHYSICAL DAMAGE) ISSUE. THE REPORTER STATED THAT THE PUMP HAD BECOME HOT TO THE TOUCH. 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
    40854 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR