BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4781850 · Received May 19, 2015

    Report

    Report Number
    2531779-2015-16556
    Event Type
    Injury
    Date Received
    May 19, 2015
    Report Date
    May 11, 2015
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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)(6) 2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/16/2015 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX (BB) DATA INDICATES A TEMP BASAL WAS ACTIVE ON (B)(6) 2015. THE TEMP BASAL WAS CANCELLED WHEN A PRIME WAS PERFORMED AT 12:54. THE BB DOES NOT SHOW A TEMP BASAL PROGRAM RUNNING @ TIME OF THE COMPLAINT. A TEMP BASAL WAS PROGRAMMED; PUMP LOCK FEATURE WAS ENABLED AND DISABLED WITH NO CHANGE OBSERVED TO THE PROGRAMMED TEMP BASAL. THERE WERE NO EAW'S IN THE ALARM HISTORY/BB ASSOCIATED WITH A TEMP BASAL CANCELLATION. INVESTIGATORS WERE UNABLE TO CONFIRM/DUPLICATE COMPLAINT OF TEMP BASAL CANCELLED WHEN PUMP IS LOCKED/UNLOCKED. THERE WAS NO DEFECT FOUND. 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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2015 ALLEGING A OTHER (UNUSUAL) ISSUE. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF OVER 27.7MMOL/L WITHOUT SYMPTOMS. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE CARE OF DIABETES MANAGEMENT. CUSTOMER SUPPORT (CS) COMPLETED TROUBLESHOOTING AND THE TEMP BASAL WAS CANCELLED AFTER PUMP LOCKING. THE PATIENT WAS INSISTENCE AND LOST CONFIDENCE. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION THE PATIENT EXPERIENCED DUE TO UNUSUAL ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325707 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Life Threatening