BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5932697 · Received September 7, 2016

    Report

    Report Number
    2531779-2016-24358
    Event Type
    Injury
    Date Received
    September 7, 2016
    Date of Event
    August 8, 2016
    Report Date
    August 10, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/10/2016 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/15/2016 WITH THE FOLLOWING FINDINGS: THE BLACK BOX (BB) SHOWED EVIDENCE OF A TIME/DATE RESET AFTER A PUMP REBOOT ON (B)(6) 2016. THE BB SHOWED A MANUAL DATE CHANGE FROM (B)(6) 2016 23:06 TO (B)(6) 2016 23:06. AND A MANUAL DATE/TIME CHANGE FROM (B)(6) 2016 01:45 TO (B)(6) 2016 13:45. THE PUMP WAS EXERCISED FOR 24HRS; AFTER 24HRS THE BATTERY WAS REMOVED FOR 6HRS AND THE BENCH TESTING CONFIRMED THAT WHEN THE BATTERY WAS REINSERTED AFTER 6HRS WITHOUT POWER, THE TIME/DATE RESET TO THE DEFAULT SETTING. A VISUAL INSPECTION CONFIRMED THAT THE INTERNAL BATTERY WAS LEAKING. THE TOTAL DAILY DOSES ADDED UP CORRECTLY AND REFLECTED THE USERS PROGRAMMED BASAL RATES. THERE WERE NO DELIVERY DEFECTS FOUND DURING DELIVERY ACCURACY TESTING AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. UNRELATED TO THE ORIGINAL COMPLAINT, THE BATTERY COMPARTMENT WAS CRACKED WITH CORROSION OBSERVED INSIDE. THE LEAK TEST CONFIRMED THE BATTERY COMPARTMENT LEAK. THE PUMP COVER WAS REMOVED AND NO FURTHER EVIDENCE OF MOISTURE DAMAGE WAS FOUND. ALSO UNRELATED, THE DISPLAY WAS DISCOLORED. 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. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2016 THE REPORTER CONTACTED ANIMAS ALLEGING THAT ON (B)(6) 2016 THE PATIENT EXPERIENCED A BLOOD GLUCOSE (BG) READING OF 475 MG/DL WITH A LARGE LEVEL OF KETONES, NAUSEA, AND VOMITING. THE PATIENT REPORTEDLY REMAINED ON INSULIN PUMP THERAPY AND DID NOT RECEIVED ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE FOR DIABETES CARE AND MANAGEMENT. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS REVEALED THAT THE PUMP'S TIME AND DATE SETTINGS RESET TO DEFAULT SETTINGS AFTER THE BATTERY WAS REMOVED FOR LESS THAN 24 HOURS. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA DUE TO THE ALLEGED TIME AND DATE RESET ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583475 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Life Threatening