BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3971640 · Received July 31, 2014

    Report

    Report Number
    2531779-2014-22003
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 17, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/02/2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED WITH INVESTIGATION. REVIEW OF THE PUMP¿S BLACK BOX FOUND THE LAST BOLUS DELIVERY OCCURRED ON (B)(6) 2014; THERE WAS A LOSS OF PRIME EVENT ON (B)(6) 204 AND THE PUMP RESUMED INSULIN DELIVERY ON (B)(6) 2014; THE LAST BASAL DELIVERY OCCURRED ON (B)(6) 2014. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE, BOLUS DELIVERIES, DELIVERY ACCURACY TEST, AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. BASAL AND BOLUS DELIVERIES DURING INVESTIGATION WERE ACCURATELY RECORDED IN THE PUMP¿S TOTAL DAILY DOSE HISTORY. 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

    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) 2014, IT WAS REPORTED THE PATIENT¿S BLOOD GLUCOSE WAS 359 MG/DL WITH MODERATE KETONE LEVELS ON AN UNSPECIFIED DATE. IT WAS REPORTED THERE WAS AN INACCURATE DELIVERY ISSUE WITH THE PUMP. NO ADDITIONAL INFORMATION WAS PROVIDED AND TROUBLESHOOTING COULD NOT BE COMPLETED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT¿S HYPERGLYCEMIA WAS REPORTEDLY ASSOCIATED WITH AN ALLEGED PUMP MALFUNCTION OF UNKNOWN CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447713 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Life Threatening