BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4123831 · Received September 26, 2014

    Report

    Report Number
    2531779-2014-27719
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORIES DID NOT FIND ANY ERRORS, ALARMS, OR WARNINGS ASSOCIATED WITH THE COMPLAINT. A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP SUCCESSFULLY COMPLETED A REWIND, LOAD, AND PRIME SEQUENCE. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ISSUES OCCURRING. THE PUMP PASSED DELIVERY ACCURACY TESTING AND WAS FOUND TO BE DELIVERING WITHIN REQUIRED SPECIFICATIONS. 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 ALLEGING THAT ON (B)(6) 2014 THE PATIENT¿S BLOOD GLUCOSE WAS 370 MG/DL WITH RAPID, DEEP BREATHING, SHORTNESS OF BREATH, CHEST PAIN, EXTREME DROWSINESS, DIFFICULTY WAKING UP, CONFUSION, NAUSEA, POLYDYPSIA, AND POLYURIA THAT WAS ATTRIBUTED TO AN ALLEGED INACCURATE DELIVERY ISSUE. THE REPORTER NOTED THE PATIENT WAS GIVEN ADVICE OVER THE PHONE BY A HEALTHCARE PROVIDER (HCP) TO TREAT WITH MANUAL INSULIN INJECTIONS AND AN INFUSION SET INSERTION SITE CHANGE. IT WAS REPORTED THE PATIENT REMAINED ON PUMP THERAPY AND THE PUMP SETTINGS WERE NOT RECENTLY CHANGED BY AN HCP. REPORTEDLY, THE ACTIVE BASAL PROGRAM MATCHED THE BASAL HISTORY; THE BASAL TOTAL DAILY DOSE HISTORY DID NOT MATCH THE ACTIVE BASAL PROGRAM. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED HYPERGLYCEMIA WAS ATTRIBUTED TO AN ALLEGED INACCURATE DELIVERY ISSUE OF UNKNOWN CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602706 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Life Threatening| R