BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3121627 · Received May 21, 2013

    Report

    Report Number
    2531779-2013-06783
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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. 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

    FOLLOW-UP #1: DATE OF SUBMISSION 02/04/2016 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/27/2016 WITH THE FOLLOWING FINDINGS:THERE WAS NO PUMP HISTORY FROM THE TIME OF THE EVENT DUE TO CONTINUED PATIENT USE. A REVIEW OF THE TOTAL DAILY DOSE HISTORY FOR THE AVAILABLE DATE RANGE 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. THE PUMP WAS EXERCISED FOR 24 HOURS AT 1 UNIT PER HOUR AND CORRECTLY RECORDED 24 UNITS DELIVERED AT THE CONCLUSION OF TESTING. NO ERRORS, ALARMS, OR WARNINGS OCCURRED DURING TESTING. A DELIVERY ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED FROM THE THREADS TO THE CASE SEAL. ALSO UNRELATED, THE DISPLAY SCREEN WAS NOTED TO BE DIM AND DISCOLORED WITH A REDDISH COLORATION.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013 REPORTING A HOSPITALIZATION AFTER A FAMILY MEMBER FOUND THE PATIENT UNRESPONSIVE ON THE FLOOR WITH A BLOOD GLUCOSE OF 540 MG/DL. THE PATIENT STATED THAT AT THE HOSPITAL, THE PATIENT¿S BLOOD GLUCOSE WAS TESTED AT 690 MG/DL; THE PATIENT WAS TREATED VIA INSULIN DRIP AND WAS RELEASED WITH BLOOD GLUCOSE LEVELS IN THE 300 MG/DL RANGE. THE PATIENT INDICATED THAT THE PUMP, SITE, AND SET WERE NOT IMPLICATED IN THE EVENT. THE PATIENT INDICATED HAVING LONG STANDING ELEVATIONS ABOVE 500 MG/DL PRIOR TO USING THE PUMP AND THE PATIENT INDICATED THAT BLOOD GLUCOSE LEVELS IN THE 300 ¿ 500 MG/DL RANGE WERE NORMAL. THE PATIENT ALSO INDICATED HAVING MULTIPLE OTHER HEALTH CONDITIONS INCLUDING CANCER, KIDNEY STONES, RECENT OPEN HEART SURGERY, FRACTURES, REMOVAL OF TITANIUM PLATES, AND BACK ISSUES. THIS REPORT IS MADE BASED ON THE ALLEGATION THAT THE PATIENT WAS HOSPITALIZED FOR HYPERGLYCEMIA WITH UNCLEAR CAUSE WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225034 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| L