BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 5425160 · Received February 9, 2016

    Report

    Report Number
    2531779-2016-03595
    Event Type
    Malfunction
    Date Received
    February 9, 2016
    Report Date
    January 12, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 02/24/2016-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 WITH INVESTIGATION. REVIEW OF THE PUMP¿S BLACK BOX REVEALED NO ABNORMAL PUMP BEHAVIOR OR RELATED ALARMS OR ISSUES. THE PUMP WAS MANUALLY SUSPENDED ON (B)(6) 2016 AT 11:06 AND MANUALLY RESUMED AT 11:18. THE PUMP WAS MANUALLY SUSPENDED ON (B)(6) 2016 AT 10:33 AND MANUALLY RESUMED AT 10:45. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE, BOLUS DELIVERIES, AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. DELIVERIES PERFORMED DURING INVESTIGATION WERE RECORDED ACCURATELY IN THE PUMP¿S HISTORY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A HISTORY/SETTINGS (HISTORY/SETTINGS ISSUE: BASAL HISTORY DID NOT MATCH ACTIVE BASAL PROGRAM) ISSUE. IT WAS REPORTED THE PATIENT'S BLOOD GLUCOSE WAS BETWEEN 250-499 WITHOUT SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE REPORTED HEALTH EVENT DOES NOT QUALIFY AS A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79652 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR