BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2922861 · Received January 18, 2013

    Report

    Report Number
    2531779-2013-00873
    Event Type
    Malfunction
    Date Received
    January 18, 2013
    Report Date
    January 8, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(4) 2013 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: THE PUMP'S HISTORY SHOWED REBOOTS AND AN UNACKNOWLEDGED AUTO TIMEOUT, PUMP SUSPENDED ALARM; THE BATTERY VOLTAGE WAS LOW AT THE TIME OF THE ALARM. THE UNCONFIRMED ALARM DRAINED THE BATTERY. DURING EVALUATION OF THE PUMP, NO DAMAGE WAS OBSERVED TO THE BATTERY CAP OR BATTERY COMPARTMENT. DURING TESTING, THE PUMP WAS EXERCISED FOR 24 HOURS WITH A 1 UNIT PER HOUR BASAL PROGRAM SUCCESSFULLY WITH NO ALARMS OR POWER INTERRUPTIONS. NO EVIDENCE OF INTERNAL MOISTURE OR DAMAGE TO THE POWER CIRCUIT WAS OBSERVED DURING INVESTIGATION OF THE PUMP.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013, REPORTING THAT HER PUMP WOULD NOT TURN ON. SHE STATED THAT SHE WAS IN THE HOSPITAL FOR TWO WEEKS AND NOT BEEN USING THE. SHE WAS DISCHARGED TODAY AND THE PUMP DID NOT TURN ON. SHE STATED THAT THERE WAS A BLANK SCREEN AND NO AUDIBLE SOUNDS. THE PATIENT REPORTED THERE IS NO TRAUMA OR MOISTURE TO THE PUMP. THERE IS NO REPORTED ADVERSE EVENT WITH THIS COMPLAINT. THIS REPORT IS MADE BASED ON THE ALLEGATION OF THE POWER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28181 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR