BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3191226 · Received June 26, 2013

    Report

    Report Number
    2531779-2013-09047
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    May 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 08/21/2012 DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/25/2012WITH THE FOLLOWING FINDINGS:A REVIEW OF THE BLACK BOX HISTORY INDICATED MULTIPLE "POWER ON RESETS" ON 05/30/2013. EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE USER GUIDE WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND/OR THE WATERPROOF FEATURE OF THE PUMP. NO EVIDENCE OF MOISTURE OR CONTAMINATION WAS NOTED INSIDE BATTERY COMPARTMENT. THE BATTERY CAP WAS UNABLE TO SECURE TO THE PUMP DUE TO THE DAMAGED BATTERY CASING. A POWER LOSS WAS OBSERVED; A TEST CAP WAS USED AND WAS ALSO UNABLE TO FULLY TIGHTEN. THE PUMP WAS EXERCISED WITH A TEST BATTERY CAP FOR 24 HOURS. NO POWER LOSS OR BATTERY RELATED WARNINGS WERE OBSERVED DURING EXERCISE. NO ISSUES WERE NOTED WITH THE TERMINAL CONTACTS. UNRELATED TO THE COMPLAINT, THE DISPLAY WAS FOUND TO BE FADED, DISCOLORED AND DIFFICULT TO READ. 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 CONTACTED ANIMAS, ALLEGING A POWER (INTERMITTENT POWER) ISSUE. REPORTEDLY, THE PUMP LOST POWER WITHOUT USER INTERVENTION. IT WAS NOTED THAT THE BATTERY HAD BEEN REPLACED THREE DAYS EARLIER. THE PATIENT NOTED THAT HE CLEANED THE BATTERY AND THE BATTERY CAP, REPLACED THE SAME BATTERY, AND NOW THE PUMP WAS EMITTING A LOW BATTERY WARNING. A REVIEW OF THE ALARM HISTORY SHOWED NO 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
    291493 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR