BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3983047 · Received August 6, 2014

    Report

    Report Number
    2531779-2014-22506
    Event Type
    Injury
    Date Received
    August 6, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 13, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED TO ANIMAS. 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

    DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/05/2014 WITH THE FOLLOWING FINDINGS: THE PUMP BLACK BOX WAS REVIEWED AND FOUND EVIDENCE OF UNEXPLAINED POWER EVENTS OCCURRING ON (B)(6) 2014 AT 17:27; THE PUMP BLACK BOX SHOWED THAT WHEN THE PUMP WAS POWERED BACK ON, THE TIME AND DATE WAS MANUALLY SET INCORRECTLY TO (B)(6) 2014 AT 03:28. THE PUMP INSULIN DELIVERY WAS RESUMED AT 07:36. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. NO ALARMS OR PUMP CONDITIONS INDICATING A MALFUNCTION WERE RECORDED IN BLACK BOX OR ALARM HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO DELIVERY RELATED DEFECTS WERE FOUND DURING TESTING.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING THAT THE PATIENT¿S BLOOD GLUCOSE DROPPED TO 29 MG/DL REQUIRING A NURSE TO ¿REVIVE¿ THE PATIENT FROM PASSING OUT. THE REPORTER INDICATED THAT THEY DID NOT REALIZE THAT THE PUMP WAS ¿BROKEN¿. THE PUMP WAS UNABLE TO BE REVIEWED AT THE TIME OF THE CALL. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPOGLYCEMIA ASSOCIATED WITH AN ALLEGATION THAT THE PUMP WAS MALFUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461113 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening| R