BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3052157 · Received April 11, 2013

    Report

    Report Number
    2531779-2013-04043
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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. 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

    DEVICE EVALUATION FOLLOW-UP #1 (B)(4): THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: UNABLE TO DUPLICATE THE COMPLAINT DURING THE INVESTIGATION. THE PUMP WAS TESTED ON A (B)(4) FLOW TEST; THE PUMP PASSED THE REQUIRED TEST AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFICATION. REVIEW OF THE BLACK BOX AND ALARM HISTORY SHOWS ON TYPICAL USAGE ALARMS AND WARNINGS. THE PROGRAMMED BASAL RATES ARE CORRECTLY REFLECTED IN THE DAILY INSULIN TOTALS. 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 V 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT ON (B)(6) 2013, SHE WAS UNCONSCIOUS AND HER HUSBAND CALLED EMS TO PROVIDE TREATMENT FOR A LOW BLOOD GLUCOSE (BG) WHICH WOULD NOT READ ON THE METER. EMS GAVE HER "BAGS OF SUGAR" TO GET BG UP. HER TARGET BG IS BETWEEN 100MG/DL-110MG/DL, AND HER BG CAME UP TO THE 100'S MG/DL. PATIENT ALLEGES FIVE EPISODES OF HYPOGLYCEMIA IN THE LAST MONTH AND ALLEGES THE LOW BG'S ARE BEING CAUSED BY TOO MUCH BASAL INSULIN. CUSTOMER TECHNICAL SUPPORT (CTS) REVIEWED PUMP AND ADVISED PATIENT THAT HISTORY ADDS UP PROPERLY. PER REVIEW OF BASAL SEGMENTS, PATIENT STATES THEY WERE PROGRAMMED AS DESIRED. REVIEWED PUMP HISTORIES, THERE WERE NO DISCREPANCIES FOUND, BOLUS AND BASAL AMOUNTS ADD UP WITH TDD, NO RELATED ALARMS. ALTHOUGH NO DEFECT FOUND IN PUMP, PATIENT STATES HER HEALTH CARE PROVIDER WANTS PUMP REPLACED FOR PATIENT'S LOW BG'S. THIS COMPLAINT IS BEING REPORTED BECAUSE A PATIENT ON PUMP THERAPY EXPERIENCED HYPOGLYCEMIA REQUIRING MEDICAL ASSISTANCE, RELATED TO AN ALLEGED PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156327 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Life Threatening