BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3873750 · Received June 16, 2014

    Report

    Report Number
    2531779-2014-17057
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Report Date
    June 11, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP¿S BLACK BOX HISTORY SHOWED THAT LOSS OF PRIME WARNINGS WITH BOTH ZERO AND NON-ZERO LOW FORCE WERE RECORDED. THE BLACK BOX HISTORY ALSO SHOWED THAT ¿NO CARTRIDGE DETECTED¿ ALARMS HAD OCCURRED. DURING TESTING, THE PUMP PERFORMED THE REWIND, LOAD, AND PRIME STEPS WITH NO ALARMS OCCURRING. THE PUMP WAS EXERCISED FOR 24 HOURS ON A 1 UNIT PER HOUR BASAL RATE WITH NO ALARMS OCCURRING. THE FORCE SENSOR CALIBRATION READING WAS FOUND TO BE OUT OF THE REQUIRED SPECIFICATIONS. THE PUMP CASE WAS REMOVED AND A TRACE ON THE FORCE SENSOR FLEX CABLE WAS FOUND TO BE CRACKED AT THE PIN. THERE WAS NO EVIDENCE OF MOISTURE OR CORROSION INSIDE THE PUMP. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE BATTERY COMPARTMENT WAS CRACKED IN TWO PLACES FROM THE GRIP TO THE CASE SEAL. THE COMPLAINT THAT THE PUMP WAS EMITTING LOSS OF PRIME WARNINGS WAS OBSERVED IN THE PUMP HISTORY BUT WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION. 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 FOR EVALUATION. 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

    THE PUMP¿S SERIAL NUMBER HAS BEEN UPDATED TO (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. IT WAS REPORTED THAT THE PUMP WAS EMITTING MULTIPLE LOSS OF PRIME WARNINGS. IT WAS NOTED THAT THE PUMP WAS ABLE TO PERFORM THE REWIND, LOAD, AND PRIME STEPS AFTER CHANGING THE CARTRIDGE. REPORTEDLY, THE USER DISCONTINUED USE OF THE PUMP AND WAS NOT ABLE TO COMPLETE TROUBLESHOOTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352083 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR