BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5414964 · Received February 6, 2016

    Report

    Report Number
    2531779-2016-03449
    Event Type
    Injury
    Date Received
    February 6, 2016
    Date of Event
    January 17, 2016
    Report Date
    January 20, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 03/04/2016-PRODUCT ANALYSIS: THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2016 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED WITHIN INVESTIGATION. REVIEW OF THE PUMP¿S BLACK BOX REVEALED NO ABNORMAL BEHAVIOR OR EVIDENCE OF AN INACCURATE DELIVERY ISSUE; THE TOTAL DAILY DOSE DELIVERY HISTORY WAS APPROPRIATE FOR THE USER PROGRAMMED DELIVERY SETTINGS. THE PUMP WAS MANUALLY SUSPENDED: FROM (B)(6) 2016, 18:08 TO (B)(6) 2016, 00:40; FROM (B)(6) 2016, 12:22 TO (B)(6) 2016, 17:02; FROM (B)(6) 2016, 17:03 TO (B)(6) 2016, 23:04. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE, BOLUS DELIVERIES, AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. THE PUMP PASSED A DELIVERY ACCURACY TEST. NO SELF-SUSPENSIONS WERE OBSERVED DURING INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS ALLEGING THE PATIENT'S BLOOD GLUCOSE ON (B)(6) 2016 WAS 44 MG/DL WITH UNSTEADINESS WHEN STANDING AND WALKING AND SEVERE HEADACHE. IT WAS REPORTED THE PATIENT WAS TREATED IN AN EMERGENCY ROOM WITH UNKNOWN TREATMENTS. THE REPORTER NOTED THE PATIENT REMAINED ON PUMP THERAPY AND THE PUMP'S SETTINGS WERE NOT RECENTLY CHANGED. DURING TROUBLESHOOTING, IT WAS REPORTED THAT THE PUMP'S BASAL HISTORY WAS APPROPRIATE FOR THE PROGRAMMED BASAL RATES AND THE TOTAL DAILY DOSE BASAL HISTORY DID NOT MATCH THE PROGRAMMED BASAL RATES. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED HEALTH EVENT WAS ATTRIBUTED TO AN UNKNOWN PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72703 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Life Threatening