BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4141375 · Received October 3, 2014

    Report

    Report Number
    2531779-2014-28340
    Event Type
    Injury
    Date Received
    October 3, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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

    FOLLOW-UP #1 PRODUCT ANALYSIS: THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/03/2015 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED DURING INVESTIGATION. REVIEW OF THE PUMP¿S BLACK BOX DATA REVEALED DATA RELEVANT TO THE COMPLAINT WAS OVERWRITTEN DUE TO EXTENDED CONTINUED PUMP USE. THE PUMP¿S TOTAL DAILY DOSE HISTORY WAS APPROPRIATE FOR THE USER PROGRAMMED BASAL RATES. NO RELATED ALARMS OR ISSUES WERE OBSERVED. 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. 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 565 MG/DL WITH NAUSEA ON AN UNSPECIFIED DATE. IT WAS REPORTED THE PATIENT REMAINED ON THE PUMP AND THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. NO FURTHER INFORMATION WAS ABLE TO BE OBTAINED AND TROUBLESHOOTING COULD NOT BE COMPLETED. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION OF THE PATIENT¿S HYPERGLYCEMIA AND THE PUMP COULD NOT BE RULED-OUT AS A CAUSE OR CONTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619465 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Life Threatening