BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4116374 · Received September 24, 2014

    Report

    Report Number
    2531779-2014-27391
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Report Date
    September 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/24/2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED WITH INVESTIGATION. REVIEW OF THE BLACK BOX REVEALED THE PUMP WAS MANUALLY SUSPENDED AT 07:34 AND RESUMED AT 08:24 ON (B)(6) 2014. BASAL HISTORY AND TOTAL DAILY DOSE BASAL HISTORY MATCHED THE USER PROGRAMMED BASAL RATES. THERE WAS NO ABNORMAL BEHAVIOR INDICATED IN THE BLACK BOX. 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. ALL DELIVERIES MADE DURING INVESTIGATION WERE ACCURATELY RECORDED IN THE BLACK BOX AND PUMP HISTORY.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING THE PUMP¿S BASAL HISTORY DID NOT MATCH ACTIVE BASAL PROGRAM. IT WAS REPORTED THE PATIENT¿S BLOOD GLUCOSE (BG) WAS BETWEEN 250-499 MG/DL WITH NO SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE REPORTED BG EXCURSION DOES NOT QUALIFY AS A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594588 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR