BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3182106 · Received June 21, 2013

    Report

    Report Number
    2531779-2013-08731
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 27, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    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 HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/19/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX HISTORY REVEALED A ¿LOAD STEP MALFUNCTION¿ WITH MULTIPLE ¿NO CARTRIDGE DETECTED¿ WARNINGS ON THE REPORTED EVENT DATE. DURING EVALUATION, THE PISTON WAS UNABLE TO DETECT THE CARTRIDGE UPON THE FIRST ¿LOAD¿ ATTEMPT. THE PUMP WAS OPENED; CONTAMINATION WAS FOUND TO THE FORCE SENSOR ASSEMBLY. THE FORCE SENSOR WAS FOUND TO BE OUT OF CALIBRATION. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED FROM THE THREADS DOWN TO THE CASE SEAL; WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF THE PUMP. ALSO UNRELATED TO THE COMPLAINT, THE DISPLAY SCREEN WAS FOUND TO BE REDDISH AND DIM. ALSO UNRELATED TO THE COMPLAINT, THE KEYPAD WAS FOUND TO BE TORN EXPOSING ¿OK¿ BUTTON KEY CONTACT. A DAMAGED KEYPAD WILL PERMIT CONTAMINATION TO PERMEATE THE BUTTONS WHICH WILL HAVE A NEGATIVE IMPACT ON BUTTON FUNCTION. THIS SITUATION IS NOT LIKELY TO RESULT IN AN ADVERSE EVENT AS THE DAMAGED KEYPAD SHOULD BE CLEARLY VISIBLE AND WARNS THE PATIENT TO DISCONTINUE USING THE PUMP. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED. ALL BUTTONS WERE FOUND TO BE RESPONSIVE; THE KEYPAD COVER WAS REMOVED, CONTAMINATION WAS FOUND UNDER ALL KEY¿S CONTACTS. THE BOLUS BUTTON COVER WAS FOUND TO BE TORN AND THE BOLUS BUTTON WAS FOUND TO BE UNRESPONSIVE. THE BOLUS BUTTON COVER WAS REMOVED; CONTAMINATION WAS FOUND UNDER THE KEY CONTACT AND ON THE WHITE SLUG. 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. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOAD STEP MALFUNCTION) ISSUE. REPORTEDLY, THE PUMP DISPENSED ALL THE INSULIN FROM THE CARTRIDGE DURING THE LOAD STEP. 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
    283504 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR