BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3760323 · Received April 21, 2014

    Report

    Report Number
    2531779-2014-10613
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Report Date
    April 3, 2014
    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 05/19/2014. DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/08/2014 WITH THE FOLLOWING FINDINGS: DURING INVESTIGATION, A REVIEW OF THE BLACK BOX SHOWED DATES 04/09/2014 TO 04/17/2014. NO EVIDENCE OF SHORT BATTERY LIFE/EXCESSIVE BATTERY USAGE WAS OBSERVED IN THE BLACK BOX. THE ALARM HISTORY SHOWED MULTIPLE REPLACE BATTERY ALARMS HAD OCCURRED. DURING TESTING, THE PUMP POWERED ON NORMALLY WITH THE RETURNED BATTERY CAP. THE BATTERY CAP WAS ABLE TO FULLY TIGHTEN TO THE PUMP. A POWER LOSS WAS NOT OBSERVED. THE BATTERY COMPARTMENT WAS INTACT. THE PUMP CURRENT DRAWS WERE FOUND TO BE WITHIN SPECIFICATIONS. THE PUMP CASE WAS REMOVED AND NO EVIDENCE OF MOISTURE OR LOOSE COMPONENTS WAS OBSERVED INSIDE THE PUMP. THE FREQUENCY OF ALARMS WAS CONFIRMED IN THE PUMP HISTORY BUT WAS NOT DUPLICATED DURING INVESTIGATION.

    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 POWER (BATTERY LIFE) ISSUE. IT WAS REPORTED THAT THE PUMP¿S BATTERY LIFE WAS LESS THAN EXPECTED BY THE USER. THE PATIENT HAD USED MULTIPLE BATTERIES FROM SEPARATE PACKAGES BUT THE ISSUE CONTINUED. A REVIEW OF THE ALARM HISTORY CONFIRMED LOW BATTERY AND REPLACE BATTERY ALARMS. 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
    240234 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR