BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2863426 · Received December 10, 2012

    Report

    Report Number
    2531779-2012-14307
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 8, 2012
    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

    FOLLOW UP #1 SUBMITTED: 12/28/2012 DEVICE EVALUATION: THE INSULIN PUMP HAS BEEN RETURNED AND ADDITIONAL INVESTIGATION WAS PERFORMED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: REVIEW OF THE BLACK BOX AND DOWNLOAD HISTORY REVEALED MULTIPLE UNUSUAL REBOOTS ON THE REPORTED FAILURE DATE DUE TO DISCHARGED BATTERY WEAR; OTHERS WERE UNEXPLAINED. ON EXAMINATION, THE THREADS ON THE BATTERY CAP THAT WAS RETURNED FOR INVESTIGATION WERE STRIPPED. THE BATTERY COMPARTMENT WAS CRACKED. ON TESTING, THE RETURNED BATTERY CAP WAS UNABLE TO HOLD AN ELECTRICAL CONNECTION WHEN APPLIED TO THE PUMP, DUPLICATING THE COMPLAINT OF INTERMITTENT POWER. WHEN A TEST CAP WAS USED FOR TESTING, THERE WERE NO FURTHER POWER INTERRUPTIONS. WITH THE TEST CAP IN PLACE, THE PUMP POWERED ON NORMALLY. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THE PUMP WAS OPENED FOR INVESTIGATION WITH NO EVIDENCE OF MOISTURE INGRESS OR DEFECT OF THE PUMP'S INTERIOR COMPONENTS.

    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. S/N (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS ALLEGING THE FOLLOWING: FOR THE LAST 4-5 DAYS, THE PUMP WILL BEEP, CHIRP, AND THEN SHUT OFF. REPORTEDLY THEY HAVE BEEN ABLE TO CHANGE THE BATTERY QUICKLY TO AVOID BLOOD GLUCOSE EXCURSIONS. BATTERIES ARE LASTING ONLY ONE DAY. ALLEGEDLY, THE PUMP LOSES POWER ABRUPTLY AND THE ONLY WARNING IS THE BEEPING AND CHIRPING. THE BATTERY TYPE MATCHES THE PUMP, AND THE BATTERY CAP IS INTACT AND SECURES TO PUMP. MOM STATES THAT THERE IS NO DAMAGE TO THE BATTERY COMPARTMENT AND SHE CHANGED THE BATTERY CAP LESS THAN 6 MONTHS AGO. WHEN TROUBLESHOOTING BEGUN, THE REPORTER STATED, THE YELLOW O-RING WAS VERY VISIBLE. THE REPORTER STATED, SHE TIGHTENED THE BATTERY CAP BUT THE YELLOW O-RING WAS STILL VISIBLE. THE REPORTER DENIES UNCONFIRMED ALARMS IN HISTORY AND DID NOT HAVE TIME TO REVIEW ALARM HISTORY FOR LOW BATTERY WARNINGS. SHE WILL CALL SUPPLIES TO ORDER A REPLACEMENT BATTERY CAP, THEN ABRUPTLY DISCONNECTED THE CALL. THIS COMPLAINT IS BEING REPORTED AS THE INTERMITTENT POWER ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR