BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4240949 · Received November 10, 2014

    Report

    Report Number
    2531779-2014-32039
    Event Type
    Injury
    Date Received
    November 10, 2014
    Report Date
    October 24, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/19/2014 WITH THE FOLLOWING FINDINGS: THE BLACK BOX HISTORY SHOWED A PUMP REBOOT AFTER A REPLACE BATTERY ALARM ON (B)(6) 2014 AT 07:09; DELIVERIES RESUMED AT 14:16. THERE WAS NO DAMAGE FOUND TO THE BATTERY COMPARTMENT OR RETURNED BATTERY CAP. THE RETURNED BATTERY CAP WAS ABLE TO FULLY TIGHTEN TO THE PUMP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER INTERRUPTIONS DUPLICATED. THE RETURNED BATTERY CAP¿S MEASUREMENTS WERE WITHIN SPECIFICATIONS. THE TOTAL DAILY DOSES ADDED UP CORRECTLY AND REFLECTED THE USER PROGRAMMED BASAL RATE. THE PUMP PASSED A 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 FOUND. THE COMPLAINT WAS VERIFIED IN THE HISTORY, BUT COULD NOT BE 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 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.

    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 OF 490 MG/DL WITH MODERATE KETONES, EXTREME DROWSINESS, AND NAUSEA ASSOCIATED WITH AN INTERMITTENT POWER ISSUE. 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), IT WAS REPORTED THAT THERE WAS NO DAMAGE TO THE BATTERY COMPARTMENT OR CAP AND THE CAP WAS ABLE TO SECURE PROPERLY ON TO THE PUMP. THE REPORTER NOTED THAT THERE WAS NO MOISTURE/CORROSION IN THE PUMP. ALSO DURING TROUBLESHOOTING, THERE WERE NO UNCONFIRMED ALARMS OBSERVED IN THE ALARM HISTORY. CTS INSTRUCTED THE USER TO TRY A NEW BATTERY FROM A NEW PACK AND THE PUMP POWERED ON APPROPRIATELY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA RELATED TO AN INTERMITTENT POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722411 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Life Threatening