BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3994348 · Received August 8, 2014

    Report

    Report Number
    2531779-2014-22855
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 23, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/17/2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED WITH INVESTIGATION. REVIEW OF THE PUMP¿S BLACK BOX REVEALED MULTIPLE LOSS OF PRIME ALARMS. THE TOTAL DAILY DOSE HISTORY CORRELATED TO THE USER PROGRAMMED BASAL RATE. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE, BOLUS DELIVERIES, AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. A DELIVERY ACCURACY TEST FOUND THE PUMP TO BE DELIVERING ACCURATELY. ALL DELIVERIES PERFORMED DURING INVESTIGATION WERE RECORDED ACCURATELY IN THE PUMP¿S HISTORY. THE FORCE SENSOR WAS FOUND TO BE CALIBRATED PER SPECIFICATION. THERE WAS NO EVIDENCE OF DAMAGE OR DEFECT TO THE PUMP¿S FORCE SENSOR CIRCUIT. 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 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACT ANIMAS ALLEGING THE PATIENT¿S BLOOD GLUCOSE WAS 327 MG/DL WITH MODERATE KETONES ON (B)(6) 2014. IT WAS REPORTED THE PUMP HAD ALARMED FOR A LOSS OF PRIME MULTIPLE TIMES. IT WAS REPORTED THE CARTRIDGE WAS BEING USED PROPERLY AND PER THE INSTRUCTIONS FOR USE. THE REPORTER NOTED THE PATIENT DID NOT RECEIVE TREATMENT OUTSIDE OF ROUTINE DIABETES MANAGEMENT AND PUMP USE WAS DISCONTINUED. THIS COMPLAINT IS BEING REPORTED BECAUSE REPORTED HYPERGLYCEMIA WAS DUE TO AN ALLEGED PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472586 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening