BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3061799 · Received April 16, 2013

    Report

    Report Number
    2531779-2013-04363
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Report Date
    March 22, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 07/01/2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, THE PUMP¿S BLACK BOX HISTORY WAS REVIEWED AND SHOWED MULTIPLE OCCURRENCES OF THE PUMP REBOOTING ON (B)(6) 2013 AND (B)(6) 2013 THRU (B)(6) 2013. A BATTERY COMPARTMENT CRACK WAS OBSERVED IN THREAD AREA. THERE WAS NO EVIDENCE OF MOISTURE CONTAMINATION FOUND INSIDE BATTERY COMPARTMENT. THE BATTERY CAP WAS NOT ABLE TO BE FULLY TIGHTENED AND CONTINUED TO SPIN DUE TO THE DAMAGED CAP THREADS. A TEST CAP WAS USED DURING TESTING AND WAS ABLE TO BE TIGHTENED. A POWER LOSS WAS NOT OBSERVED WITH EITHER BATTERY CAP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER LOSS OR POWER RELATED WARNINGS OBSERVED. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE CONTAMINATION WAS FOUND INSIDE PUMP. THE BATTERY TERMINAL CONTACTS WERE INSPECTED AND THERE WAS NO EVIDENCE OF INTERMITTENT CONTACT. THE ISSUE OF INTERMITTENT POWER WAS NOT DUPLICATED DURING THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. IT WAS REPORTED THAT THE PUMP REBOOTED MULTIPLE TIMES WITHOUT USER INTERVENTION. 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
    161891 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR