BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5159497 · Received October 19, 2015

    Report

    Report Number
    2531779-2015-37732
    Event Type
    Injury
    Date Received
    October 19, 2015
    Report Date
    September 30, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/03/2015 WITH THE FOLLOWING FINDINGS: THE MAX TOTAL DAILY DOSE (TDD) WAS SET TO 75.0U. THE TDD TOTALS FOR (B)(6) 2015 ARE 74.9959U; BASAL WAS 24.25U AND THE BOLUS TOTALS WERE 50.74U. THE USER REACHED MAX TDD; NO FURTHER DELIVERIES COULD BE MADE UNTIL THE TIME WENT TO (B)(6) 2015 00:00. DELIVERIES WERE INTERRUPTED FROM (B)(6) 2015 AT 19:26 TO 20:02 AND FROM (B)(6) 2015 AT 20:02 TO (B)(6) 2015 00:02 DUE TO ¿NO DELIVERY, EXCEEDS TDD¿ WARNING. THE TDD¿S 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. THERE WERE NO ERRORS, ALARMS OR WARNINGS DURING TESTING. 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) 2015, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT ON AN UNSPECIFIED DATE, THE PATIENT EXPERIENCED A BLOOD GLUCOSE OVER 600 MG/DL ASSOCIATED WITH AN INACCURATE DELIVERY ISSUE. REPORTEDLY, THE PATIENT DISCONTINUED THE INSULIN PUMP AND WAS ADVISED BY A FAMILY MEMBER TO GO TO THE EMERGENCY ROOM. TROUBLESHOOTING WAS NOT COMPLETED AT THE TIME OF THE CALL AND THE REPORTER COULD NOT BE REACHED FOR FURTHER INFORMATION. IT WAS REPORTED THAT THE PATIENT RECEIVED A WARNING THAT THE TOTAL DAILY DOSE WAS AT A MAXIMUM LEVEL. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION THE PATIENT EXPERIENCED WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690245 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R