BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4863861 · Received June 23, 2015

    Report

    Report Number
    2531779-2015-20780
    Event Type
    Injury
    Date Received
    June 23, 2015
    Report Date
    June 7, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 08/13/2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/24/2015 WITH THE FOLLOWING FINDINGS: THE PUMP HISTORY SHOWED THAT THE PUMP WAS MANUALLY SUSPENDED ON (B)(6) 2015 AT 11:03. THE SUSPEND WAS CONFIRMED MULTIPLE TIMES; DELIVERIES NEVER RESUMED. THE PUMP WAS MANUALLY SUSPENDED ON (B)(6) 2015 AT 20:00 AND MANUALLY RESUMED AT 20:48. THE PUMP WAS EXERCISED FOR 24HRS WITH A 2.0U/HR BASAL RATE AND AT THE END OF TESTING THE BASAL HISTORY CORRECTLY SHOWED 2.0U AND TOTAL DAILY DOSE (TDD) CORRECTLY SHOWED 48.0U. 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. 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 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) 2015, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT ON AN UNSPECIFIED DATE, THE PATIENT HAD EXPERIENCED BLOOD GLUCOSE LEVELS IN THE 500¿S MG/DL WITH EXTREME DROWSINESS, POLYDYPSIA, SYMPTOMS OF DEHYDRATION AND TRACE KETONES 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 AND MANAGEMENT. DURING TROUBLESHOOTING WITH CUSTOMER TECHNICAL SUPPORT (CTS), IT WAS REVEALED THAT THE BASAL DELIVERY TOTALS IN THE TOTAL DAILY DOSE DID NOT MATCH THE ACTIVE BASAL PROGRAM TOTAL; HOWEVER, THE BASAL HISTORY MATCHED THE ACTIVE BASAL PROGRAM SETTINGS. IT WAS REPORTED THAT THE PATIENT¿S HEALTHCARE PROVIDER MADE RECENT CHANGES TO THE PATIENT¿S BASAL RATE. CTS DETERMINED THAT THE DATE WAS INCORRECT, BUT DID CAUSE THE BG ISSUE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA BECAUSE OF AN INACCURATE DELIVERY ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406256 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Life Threatening