BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4100099 · Received September 18, 2014

    Report

    Report Number
    2531779-2014-26696
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 10/29/2014 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP BLACK BOX DATA REVEALED LOSSES OF PRIME ASSOCIATED WITH LOW NON-ZERO FORCES AND ZERO FORCES. A LOSS OF PRIME WAS NOT DUPLICATED DURING TESTING. THE FORCE SENSOR CALIBRATION READING WAS WITHIN SPECIFICATIONS. THE PUMP CASE WAS REMOVED AND THE TRACE ON THE FORCE SENSOR FLEX WAS CRACKED AT THE PIN. NO EVIDENCE OF MOISTURE INGRESS WAS FOUND. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT WAS OBSERVED TO BE CRACKED.

    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.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME (LOSS OF PRIME) ISSUE. THE REPORTER STATED THAT A LOSS OF PRIME EVENT HAD OCCURRED 3 OR MORE TIMES WITH AT LEAST 3 SEPARATE CARTRIDGES FROM 2 SEPARATE BOXES IN 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
    578411 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR