BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4131266 · Received October 1, 2014

    Report

    Report Number
    2531779-2014-27994
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 19, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION (B)(4) 2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: THE TOTAL DAILY DOSE (TDD) HISTORY SHOWED THAT THE PUMP WAS RUNNING ON THE INCORRECT YEAR FROM (B)(4) 2014. THE PUMP HISTORY SHOWED A REPLACE CARTRIDGE ALARM ON (B)(4) 2014 AT 19:09; THE NEXT PRIME WAS RECORDED AT 21:37. THERE WAS TYPICAL USAGE ALARMS OBSERVED IN THE ALARM HISTORY. THE TDDS ADDED UP CORRECTLY AND REFLECTED THE USERS PROGRAMMED BASAL RATE. A DELIVERY ACCURACY TEST WAS SUCCESSFULLY COMPLETED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN REQUIRED RANGE. THERE WERE NO ERRORS, ALARMS, OR WARNINGS DURING THE 24 HOUR TESTING. THE ORIGINAL COMPLAINT COULD NOT BE DUPLICATED. UNRELATED TO THE ORIGINAL COMPLAINT, THE DISPLAY HAD A PINKISH CONTRAST. 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.

    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 (BG) OF 502 MG/DL WITH MODERATE KETONES, HEADACHE, SYMPTOMS OF DEHYDRATION, AND DID NOT FEEL WELL IN GENERAL ASSOCIATED WITH AN INACCURATE DELIVERY ISSUE. REPORTEDLY, THE PATIENT REMAINED ON THE INSULIN PUMP AND DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS REVEALED THAT THE BASAL DELIVERY TOTALS IN THE TOTAL DAILY DOSE DID MATCH THE ACTIVE BASAL PROGRAM, THE BASAL HISTORY MATCHED THE ACTIVE BASAL PROGRAM SETTINGS, AND THE BOLUS TOTALS MATCHED AND WERE ALL RECORDED AS PROGRAMMED. THE PATIENT WAS ABLE TO DELIVER ONE UNIT VIA AIR BOLUS WHILE ON THE PHONE WITH CTS AND IT DID RECORD CORRECTLY IN THE PUMP¿S HISTORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA BASED ON THE ALLEGED INACCURATE DELIVERY OF INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610378 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Life Threatening