BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3251026 · Received July 29, 2013

    Report

    Report Number
    2531779-2013-11986
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS FOR EVALUATION; HOWEVER, PRODUCT INVESTIGATION HAS NOT BEEN COMPLETED. ONCE EVALUATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 10/09/2013. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/18/2013 WITH THE FOLLOWING FINDINGS:DURING INVESTIGATION, A REVIEW OF THE PUMP¿S HISTORY SHOWED MULTIPLE CALL SERVICE ALARMS OBSERVED IN BLACK BOX AND ALARM HISTORY. THERE WERE NO PUMP REBOOTS OBSERVED THAT WERE NOT ASSOCIATED WITH A CALL SERVICE ALARM. NO DAMAGE WAS OBSERVED TO THE BATTERY COMPARTMENT. THE BATTERY CAP WAS NOT RETURNED WITH THE PUMP; A TEST CAP WAS USED FOR TESTING PURPOSES. SHORTLY AFTER THE PUMP POWERING ON A CALL SERVICE ALARM WAS DISPLAYED. THE SOFTWARE TO THE PROCESSOR WAS RELOADED AND THE PUMP POWERED ON PROPERLY WITH NO ALARMS. DURING TESTING, THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO FURTHER ALARMS OCCURRING. NO POWER ISSUES OCCURRED DURING THE TESTING. UNRELATED TO THE COMPLAINT, THE BOLUS BUTTON WAS FOUND TO BE MISSING FROM THE PUMP. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE POWER CIRCUIT. THE ISSUE OF INTERMITTENT POWER WAS NOT ABLE TO BE DUPLICATED DURING THE 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CLAIMED THE ANIMAS INSULIN PUMP HAS INTERMITTENT POWER ISSUES. THE SUBJECT PUMP ALLEGEDLY REPEATEDLY REBOOT. THE SUBJECT PUMP DID NOT HAVE PHYSICAL DAMAGE OR MOISTURE WITHIN. THERE WAS NO EVIDENCE OF PRODUCT MISUSE. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351960 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR