BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4120292 · Received September 26, 2014

    Report

    Report Number
    2531779-2014-27574
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Report Date
    September 16, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    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

    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 A LOSS OF PRIME WITH NON-ZERO FORCE WAS RECORDED. 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 WITHIN THE REQUIRED SPECIFICATIONS. THE PUMP CASE WAS REMOVED AND NO DEFECTS WERE FOUND TO THE FORCE SENSOR FLEX. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE DISPLAY WAS FADED AND DISCOLORED. ALSO UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THAT THE BATTERY COMPARTMENT THREADS WERE CRACKED. THE BATTERY COMPARTMENT WAS ALSO CRACKED FROM THE GRIP PAD TO THE CASE SEAL IN TWO LOCATIONS. THERE WAS NO EVIDENCE OF CORROSION FOUND IN THE BATTERY COMPARTMENT. NO BATTERY OR CARTRIDGE CAPS WERE RETURNED WITH THE PUMP. TEST CAPS WERE USED TO COMPLETE ALL TESTING. THE COMPLAINT THAT THE PUMP WAS EMITTING LOSS OF PRIME ALARMS WAS OBSERVED IN THE PUMP HISTORY BUT WAS NOT ABLE TO BE DUPLICATED DURING INVESTIGATION.

    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 LOSS OF PRIME OCCURRED WITH AT LEAST THREE CARTRIDGES FROM TWO SEPARATE BOXES WITHIN A 30 DAY PERIOD. 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
    601644 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR