BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3893029 · Received June 24, 2014

    Report

    Report Number
    2531779-2014-18169
    Event Type
    Injury
    Date Received
    June 24, 2014
    Report Date
    June 18, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/31/2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE CONFIRMED OR DUPLICATED WITH INVESTIGATION. REVIEW OF THE PUMP¿S BLACK BOX REVEALED NO RELATED ISSUES OR ALARMS. THE LAST BASAL AND BOLUS DELIVERIES WERE COMPLETED ON (B)(4) 2014. THE PUMP¿S TOTAL DAILY DOSE BASAL HISTORY CORRECTLY MATCHED THE PROGRAMMED BASAL RATE. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE, BOLUS DELIVERIES, AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. THE PUMP¿S DELIVERY ACCURACY WAS FOUND TO BE WITHIN SPECIFICATION WITH 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.

    Additional Manufacturer Narrative · 1

    THE PUMP 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, THE REPORTER CONTACTED ANIMAS, ALLEGING THE PATIENT¿S BLOOD GLUCOSE (BG) WAS 50-270 MG/DL WITH EXTREME DROWSINESS, DIFFICULTY WAKING UP, AND CONFUSION ON AN UNSPECIFIED DATE. THE REPORTER NOTED THE PATIENT DID NOT RECEIVE TREATMENT ABOVE AND BEYOND ROUTINE DIABETES MANAGEMENT AND THERE WERE NO RECENT CHANGES TO THE PUMP¿S SETTINGS. IT WAS REPORTED STATED THAT PUMP USE HAD BEEN DISCONTINUED. THE REPORTER NOTED DURING TROUBLESHOOTING THAT THE PUMP¿S BASAL HISTORY DID NOT MATCH THE PUMP¿S ACTIVE BASAL PROGRAMMING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE HYPOGLYCEMIC AND HYPERGLYCEMIC EVENTS WERE ASSOCIATED WITH AN INACCURATE DELIVERY ISSUE OF UNKNOWN CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367623 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening