BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6537087 · Received May 2, 2017

    Report

    Report Number
    2531779-2017-09125
    Event Type
    Injury
    Date Received
    May 2, 2017
    Date of Event
    March 22, 2017
    Report Date
    April 5, 2017
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/17/2017 WITH THE FOLLOWING FINDINGS: THE EVENT DATE OF (B)(6) 2017 WAS NOT AVAILABLE IN THE BLACK BOX. THE BLACK BOX SHOWED A MANUAL DATE/TIME CHANGE FROM (B)(6) 2017 20:11 TO (B)(6) 2017 20:15. THERE WAS A PUMP REBOOTS ON (B)(6) 2017 AT 23:54 IN WHICH THE TIME/DATE WAS SET TO (B)(6) 2017 12:56 WHEN THE PUMP WAS TURNED BACK ON. EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED 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. THE TOTAL DAILY DOSES ADDED UP CORRECTLY AND REFLECTED THE USERS PROGRAMMED BASAL RATES. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN RANGE. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY WAS DISCOLORED AND THE BATTERY COMPARTMENT WAS CRACKED. 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).

    Additional Manufacturer Narrative · 1

    THIS 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 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) 2017, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT WAS TREATED IN THE EMERGENCY ROOM (ER) WITH A LOW BLOOD GLUCOSE (BG) OF 38 MG/DL WITH NO REPORTED SYMPTOMS ASSOCIATED WITH A TIME/DATE RESET ISSUE ON (B)(6) 2017. REPORTEDLY, THE PATIENT CONTINUED PUMP THERAPY AND WAS TREATED WITH INTRAVENOUS (IV) GLUCOSE AND RECEIVED FOOD AND DRINK AS TREATMENT (PEANUT BUTTER AND JELLY SANDWICH). DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS REVEALED THAT THE TIME AND DATE RESET TO DEFAULT WHEN THE BATTERY WAS REMOVED FROM THE PUMP FOR LESS THAN 24 HOURS. THE REPORTER STATED THAT WHEN CHANGING THE BATTERY THE USER DID NOT KNOW HOW TO CHANGE THE TIME FROM AM TO PM AND A FAMILY MEMBER CALLED THE AMBULANCE AT 4AM BECAUSE THE USER¿S BG WAS IN THE LOW 20'S. THE USER WAS THEN TAKEN TO THE ER BY AMBULANCE, RECEIVED THE STATED TREATMENT AND WAS RELEASED AFTER 4 HOURS. 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
    317939 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R