BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2830612 · Received November 13, 2012

    Report

    Report Number
    2531779-2012-13549
    Event Type
    Malfunction
    Date Received
    November 13, 2012
    Report Date
    October 16, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 12/27/2012-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWS REBOOTING HAD OCCURRED. VISUAL INSPECTION REVEALED A CRACK IN THE BATTERY COMPARTMENT AND STRIPPED THREADS ON THE BATTERY CAP. THE BATTERY CAP WAS UNABLE TO MAINTAIN AN ELECTRICAL CONNECTION. REBOOTING AND POWER LOSS WAS DUPLICATED. A TEST BATTERY CAP WAS USED TO COMPLETE INVESTIGATION. THE PUMP POWERS ON NORMALLY WITH NO ALARMS. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO FURTHER POWER ISSUES OCCURRING. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED THE INTERNAL CLOCK BATTERY ON THE PCB BOARD HAD FAILED. THE PUMP WOULD NOT RETAIN THE USER PROGRAMMED DATE AND TIME SETTINGS UPON REMOVAL OF THE PRIMARY AA BATTERY. WHEN A NEW AA BATTERY IS INSERTED THE PUMP DISPLAYS THE DEFAULT DATE AND TIME WHICH MUST BE MANUALLY CONFIRMED (OR RESET) BY THE USER IN ORDER TO PROCEED.

    Additional Manufacturer Narrative · 1

    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. ANIMAS HAS RECEIVED THE PUMP INVOLVED WITH THE COMPLAINT ON (B)(4) 2012 BUT HAVE NOT COMPLETED INVESTIGATIONS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE REPORTER CONTACTED ANIMAS TO REPORT AN INTERMITTENT POWER ISSUE WITH THE PUMP. THE REPORTER STATED THE PUMP KEPT ON REBOOTING BECAUSE THE BATTERY CAP WAS NOT STAYING ON THE PUMP. HE HAS ALREADY REPLACED THE BATTERY CAP BUT THE ISSUE PERSISTED. HE INDICATED THAT THE YELLOW O-RING IS VISIBLE BUT CLAIMED THERE WAS NO VISIBLE DAMAGE TO THE PUMP. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THERE IS NO INDICATION THAT THE PUMP CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. BASED ON THE PROVIDED INFORMATION, THIS COMPLAINT IS BEING REPORTED BECAUSE THE INTERMITTENT POWER ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. A REPLACEMENT PUMP WAS SENT TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR