BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2925369 · Received January 22, 2013

    Report

    Report Number
    2531779-2013-01011
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Report Date
    January 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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 04/25/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY SHOWED THAT THE LAST BASAL DELIVERY OCCURRED ON (B)(4) 2013 AT 7:53PM. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. A DELIVERY INTERRUPTION WAS OBSERVED IN THE HISTORY DUE TO A ONE HOUR SUSPEND ON (B)(4) 3012. THERE WERE NO UNUSUAL ALARMS OBSERVED IN THE ALARM HISTORY. THE PUMP POWERS ON NORMALLY AND PRIMES CORRECTLY. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO DELIVERY ISSUES AND NO ALARMS OCCURRING. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THE FORCE SENSOR WAS OUT OF CALIBRATION. THERE WAS NO DAMAGE FOUND TO THE FORCE SENSOR OR POWER CIRCUIT.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(4) 2013 REPORTING THAT OVER THE PAST THREE WEEKS THEIR BLOOD GLUCOSE (BG) LEVELS HAVE BEEN RANGING FROM -300MG/DL WITH INCREASED URINATION, THIRST AND DECREASED APPETITE. THE REPORTED BG WAS NOT INDICATIVE OF A SERIOUS INJURY AND DOES NOT MEET THE ANIMAS CRITERIA OF AN ADVERSE EVENT. THE PATIENT STATED THAT CHANGED THE INSET, INSULIN AND PUMP SETTINGS WITH THE LAST SEVERAL DAYS. THE PATIENT STATED THAT THE PUMP WAS EXPOSED TO AIRPORT SECURITY. TROUBLESHOOTING WITH CUSTOMER SUPPORT (CS) INDICATED THAT THE ADVANCED FEATURES WERE REVIEWED AND THE ISF, RATIO AND BG TARGETS ARE ADEQUATELY PROGRAMMED. THERE WERE NO ASSOCIATED ALARMS IN HISTORY, ALL BOLUSES CONFIRMED, THE TOTAL DAILY DOSE WAS ACCURATE, AND THE PRIME TOTALS WERE ACCURATE. CS EVALUATED THAT THE PUMP APPEARS TO BE WORKING ADEQUATELY. THIS REPORT IS BEING MADE DUE TO THE HISTORY SETTINGS/INACCURATE DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30693 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR