BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3123641 · Received May 22, 2013

    Report

    Report Number
    2531779-2013-06855
    Event Type
    Injury
    Date Received
    May 22, 2013
    Report Date
    April 29, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/29/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S HISTORY SHOWED THAT THE LAST BASAL DELIVERY AND LAST BOLUS WERE RECORDED ON 06/18/2013. THERE WERE NO ALARMS ASSOCIATED WITH THE COMPLAINT IN THE HISTORY. THE USER¿S PROGRAMMED BASAL RATES WERE CORRECTLY REFLECTED IN THE DAILY INSULIN DELIVERY TOTALS. DURING TESTING, 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 ALLEGING ELEVATED BLOOD GLUCOSE (BG) OVER 500 MG/DL THAT WAS NOT RESOLVED BY SITE/SET CHANGE. NO FURTHER INFORMATION WAS PROVIDED REGARDING RESOLUTION OF THE ELEVATED BG. THE PATIENT WAS UNABLE TO PERFORM TROUBLESHOOTING OF THE PUMP WITH ANIMAS CUSTOMER TECHNICAL SUPPORT (ACTS) AT THE TIME OF THE CALL AND WAS INSTRUCTED BY ACTS TO CALL BACK TO PERFORM TROUBLESHOOTING. THE PATIENT DID NOT CALL BACK TO PERFORM TROUBLESHOOTING OF THE PUMP. ACTS MADE SEVERAL ATTEMPTS TO CONTACT THE PATIENT IN FOLLOW UP TO PERFORM TROUBLESHOOTING; HOWEVER, THE PATIENT DID NOT RESPOND. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGED ELEVATED BG WHILE ON INSULIN PUMP THERAPY. THERE WAS NOT ENOUGH INFORMATION TO DETERMINE IF THE INSULIN PUMP WAS A CAUSE OR CONTRIBUTOR OF THE ALLEGED ELEVATED BG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225587 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR