BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4221274 · Received November 3, 2014

    Report

    Report Number
    2531779-2014-31270
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    October 17, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/26/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX HISTORY REVEALED AN UNEXPLAINED PUMP REBOOT ON 10/14/2014 AT 14:24; DELIVERIES RESUMED WHEN THE PUMP WAS PRIMED AT 20:02. ON 10/16/2014, A REPLACE CARTRIDGE ALARM WAS RECORDED AND DELIVERIES RESUMED WHEN THE PUMP WAS PRIMED AT 21:19. THERE WAS NO DAMAGE FOUND TO THE BATTERY COMPARTMENT OR RETURNED BATTERY CAP. THE CAP MEASURED WITHIN SPECIFICATIONS AND WAS ABLE TO FULLY ATTACH TO THE PUMP. A 24 HOUR DURATION TEST WAS COMPLETED WITH NO PUMP REBOOTS DUPLICATED. THE TOTAL DAILY DOSES CORRECTLY ADDED UP AND THE PUMP PASSED THE DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. THE PUMP COVER WAS REMOVED AND THERE WAS NO EVIDENCE OF INTERNAL MOISTURE OR DAMAGE TO THE POWER CIRCUIT. THE COMPLAINT WAS VERIFIED IN THE HISTORY, BUT NOT DUPLICATED DURING THE INVESTIGATION. 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.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED A BLOOD GLUCOSE OVER 500 MG/DL WITH NAUSEA AND VOMITING ASSOCIATED WITH INTERMITTENT POWER TO THE PUMP. REPORTEDLY, THE PATIENT REMAINED ON THE PUMP AND DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), THE USER WAS ABLE TO USE A NEW BATTERY AND THE PUMP POWERED ON APPROPRIATELY. IT WAS REPORTED THAT THERE WAS NO DAMAGE TO THE BATTERY COMPARTMENT OR BATTERY CAP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA DUE TO INTERMITTENT POWER TO THEIR INSULIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701721 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Life Threatening