BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3790511 · Received May 5, 2014

    Report

    Report Number
    2531779-2014-12480
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    April 22, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    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 CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #1 SUBMITTED 06/10/2014: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 06/03/2014 WITH THE FOLLOWING RESULTS: TESTING WAS UNABLE TO REPRODUCE ANY ALARMS DURING INVESTIGATION. THE PUMP PASSED THE DELIVERY ACCURACY TESTING. OPENED PUMP AND REMOVED FROM CASE: INSPECTED CIRCUIT BOARDS WITH NO DEFECT FOUND. UNRELATED TO THE CASE, THE BATTERY COMPARTMENT WAS CRACKED FROM THE CASE SEAL TO THE GRIP. OPENED PUMP AND REMOVED FROM CASE: NO MOISTURE OR CORROSION FOUND IN PUMP. ADDITIONALLY, THE DISPLAY WAS FADED AND PINK. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THE FOLLOWING: THE PATIENT IS HOSPITALIZED WITH A DIAGNOSIS OF DIABETIC KETOACIDOSIS (DKA). LARGE KETONES ARE REPORTED. TREATMENT INCLUDES IV FLUIDS AND IV INSULIN. TROUBLESHOOTING WITH CUSTOMER SUPPORT REVEALED THE PUMP HAD EMITTED A CALL SERVICE ALARM 3 TIMES IN THE LAST 30 DAYS. PATIENT HAS DISCONTINUED USE OF THIS PUMP, AND THE PUMP WILL BE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT DEVELOPING DKA, AND BECAUSE THE CALL SERVICE ALARM ISSUE WAS NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268400 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization