BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3993522 · Received August 8, 2014

    Report

    Report Number
    2531779-2014-22836
    Event Type
    Injury
    Date Received
    August 8, 2014
    Report Date
    July 21, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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

    PRODUCT ANALYSIS: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 08/19/2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED WITH INVESTIGATION. REVIEW OF THE PUMP¿S HISTORY FOUND NO ALARMS OR ISSUES RELATED TO THE COMPLAINT. THE LAST BASAL DELIVERY OCCURRED ON (B)(6) 2014. BASAL AND BOLUS DELIVERIES IN THE HISTORY MATCHED THE TOTAL DAILY DOSE HISTORY; THE BASAL HISTORY WAS FOUND TO ACCURATELY REFLECT THE PROGRAMMED BASAL RATE. THE KEYPAD BUTTONS AND BOLUS BUTTON WERE APPROPRIATELY RESPONSIVE. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE, BOLUS DELIVERIES, AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. THE PUMP SUCCESSFULLY COMPLETED A DELIVERY ACCURACY TEST WITHOUT ISSUE. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED THE DISPLAY SCREEN WAS DIM AND DISCOLORED. 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 THE PATIENT¿S BLOOD GLUCOSE WAS 41 MG/DL WITH UNSTEADINESS WHEN STANDING AND WALKING, SEVERE DIZZINESS, AND SEVERE HEADACHE ON AN UNKNOWN DATE. IT WAS REPORTED THE PATIENT DID NOT RECEIVE ANY TREATMENT OUTSIDE OF ROUTINE DIABETES MANAGEMENT AND REMAINED ON PUMP USE. REPORTEDLY, THE PATIENT¿S HEALTH CARE PROVIDER (HCP) RECENTLY CHANGED THE PUMP¿S BASAL RATE SETTING. THE REPORTER NOTED THE PUMP WAS CALCULATING BOLUSES CORRECTLY; THE BASAL HISTORY WAS ACCURATELY REFLECTED IN THE BASAL HISTORY RECORDED IN THE TOTAL DAILY DOSE HISTORY; THE BASAL HISTORY MATCHED THE ACTIVE BASAL PROGRAM; THE BOLUS HISTORY MATCHED THE BOLUS HISTORY IN THE TOTAL DAILY DOSE HISTORY. DURING TROUBLESHOOTING WITH ANIMAS CUSTOMER TECHNICAL SERVICE, THE REPORTER NOTED THE PUMP WAS ABLE TO SUCCESSFULLY DELIVER AN AIR BOLUS, WHICH WAS ACCURATELY RECORDED IN THE PUMP¿S HISTORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED HYPOGLYCEMIA WAS ATTRIBUTED TO AN ALLEGED INACCURATE DELIVERY ISSUE FROM AN UNKNOWN PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472170 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening