BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2821574 · Received November 6, 2012

    Report

    Report Number
    2531779-2012-13221
    Event Type
    Injury
    Date Received
    November 6, 2012
    Report Date
    October 10, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    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. (B)(6).

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX BEGINS ON 05/26/2014. THE PUMP WAS USED AFTER THE ORIGINAL COMPLAINT DATE (B)(6) 2012 AND ALL HISTORIES AND BLACK BOX DATA FOR EVENT HAVE BEEN OVERWRITTEN. THE AVAILABLE PUMP HISTORY SHOWS NO ALARMS RELATED TO THE COMPLAINT. THE TOTAL DAILY DOSE ADDS UP CORRECTLY AND REFLECTS THE USERS PROGRAMMED BASAL RATE. THE PUMP PASSED A DELIVERY ACCURACY TEST; AND IT WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATION. A FORCE SENSOR CALIBRATION CHECK SHOWED THE PUMP IS NOT DETECTING THE CORRECT FORCE AT 5 POUNDS. REMOVED PUMP COVER; THE FORCE SENSOR RESISTANCE WAS FOUND TO BE IN SPECIFICATIONS. INTERNAL MOISTURE WAS FOUND ON THE PCB AND INTERNAL COMPONENTS. UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CLAIMED THE PATIENT'S BLOOD GLUCOSE READING WAS ELEVATED AROUND 300 MG/DL TO 400 MG/DL WITH SIGNS AND SYMPTOMS OF KETONES AND FATIGUE. THE PATIENT REMAINED ON THE INSULIN PUMP, CHANGED THE INFUSION SITE, AND TOOK 2 UNITS OF CORRECTION VIA THE PUMP. THE PATIENT'S BLOOD GLUCOSE WAS 340 MG/DL AT THE TIME OF THE CALL TO ANIMAS. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE CONCLUDED THERE WAS NO PUMP MALFUNCTION ASSOCIATED WITH THE ALLEGED EVENT. THE ADVANCE FEATURES AND THE BASAL SEGMENT ARE CORRECTLY PROGRAMMED ACCORDING TO THE PATIENT'S USAGE AT THE TIME OF THE EVENT. THE DATE AND TIME WAS CONFIRMED TO BE ACCURATE. THE PUMP DELIVERED INSULIN ACCORDINGLY AND NO INACCURATE DELIVERY ISSUE WAS FOUND. THERE WAS NO PRODUCT MISUSED. FURTHER INVESTIGATION INTO OTHER FACTORS THAT COULD CONTRIBUTE TO THE ALLEGED INCIDENT REVEALED THE PATIENT IS 10 YEARS OLD AND MAY BE BEGINNING PUBERTY. THE REPORTER WILL CONTACT THE PATIENT'S HCP TO EVALUATE HIS INSULIN REGIMEN. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT HAD ELEVATED BLOOD GLUCOSE READING AND KETONES TO SUGGEST HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY. THERE WAS NO PRODUCT DEFECT; HOWEVER, IT IS NOT CLEAR IF DIABETES MANAGEMENT, INTENTIONAL MISUSE, OR USE ERROR WAS ASSOCIATED WITH THE REPORTED EVENT.

    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 10 YR Life Threatening