BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5673737 · Received May 23, 2016

    Report

    Report Number
    2531779-2016-10360
    Event Type
    Injury
    Date Received
    May 23, 2016
    Date of Event
    May 6, 2016
    Report Date
    May 7, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 06/14/2016 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/01/2016 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX INDICATED A MANUAL DATE CHANGED FROM (B)(6) 2016 05:13 TO (B)(6) 2016 05:13. A REBOOT OCCURRED ON (B)(6) 2016 05:24; THE PUMP WAS POWERED BACK ON AND DELIVERIES RESUMED (B)(6) 2016 17:31. A REBOOT OCCURRED (B)(6) 2016 16:05; WHEN THE PUMP WAS POWERED BACK ON THE TIME AND DATE WERE SET TO (B)(6) 2016 04:20. A REBOOT OCCURRED (B)(6) 2016 05:20; THE PUMP WAS POWERED BACK ON (B)(6) 2016 05:25. THEN A REBOOT OCCURRED ON 05:27. THE PUMP WAS POWERED BACK ON AND DELIVERIES RESUMED (B)(6) 2016 17:30. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP SUCCESSFULLY COMPLETED A REWIND, LOAD, AND PRIME SEQUENCE. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES OCCURRING. THE PUMP PASSED DELIVERY ACCURACY TESTING AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED. UNRELATED TO THE ORIGINAL COMPLAINT, INVESTIGATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED AND 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.

    Additional Manufacturer Narrative · 1

    THE ALLEGED TIME/DATE RESET ISSUE IS NOT LIKELY TO CAUSE AN ADVERSE EVENT BECAUSE THE PUMP DISPLAYS THE VERIFY SCREEN AFTER IT IS REBOOTED AND THE TIME AND DATE MUST BE SET TO CONFIRM THE VERIFY SCREEN. 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) 2016 THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT EXPERIENCED LOW BLOOD GLUCOSE (BG) ASSOCIATED WITH A TIME/DATE RESET ISSUE. THE PATIENT REPORTEDLY EXPERIENCED A BG OF 48MG/DL ON (B)(6) 2016 AND A BG OF 47MG/DL ON (B)(6) 2016, BOTH WITH SYMPTOMS OF SWEATING, ANXIETY, AND DIZZINESS. REPORTEDLY, THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT AND REMAINED ON THE PUMP. THE REPORTER NOTED THAT THE TIME AND DATE HAD RESET TO DEFAULT SETTINGS WITH A BATTERY CHANGE A "COUPLE DAYS" PRIOR TO THE BG EXCURSIONS AND THE USER HAD INCORRECTLY SET THE AM AND PM SETTINGS WHEN RESETTING THE TIME. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA ASSOCIATED WITH A TIME/DATE RESET ISSUE, WITH USE ERROR AS A CONTRIBUTING FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329082 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening