BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3230169 · Received July 16, 2013

    Report

    Report Number
    2531779-2013-11006
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 DATE OF SUBMISSION 10/02/2013 - DEVICE EVALUATION:THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS 09/12/2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY SHOWED THAT THE ¿LOW CARTRIDGE WARNING LEVEL¿ WAS SET TO 20U. THE PUMP HISTORY SHOWED SEVERAL LOW CARTRIDGE WARNINGS; INSULIN REMAINING IN THE PUMP AT TIME OF WARNINGS WAS AT OR BELOW 20U. A ¿LOW CARTRIDGE¿ WARNING WAS REPRODUCED DURING INVESTIGATION WITH THE WARNING LEVEL SET TO 20U; THE PUMP GAVE THE APPROPRIATE SOUND AND DISPLAYED THE CORRECT MESSAGE ON THE SCREEN. THE ISSUE OF THE ABSENCE OF A LOW CARTRIDGE ALARM WAS NOT ABLE TO BE DUPLICATED DURING TESTING. 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.

    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) 2013, THE REPORTER CLAIMED THE ANIMAS INSULIN PUMP HAS NOT BEEN GETTING LOW CARTRIDGE ALARMS WHEN THE CARTRIDGE IS BELOW 20 UNITS. DURING THE TROUBLESHOOTING, THE ALARM HISTORY REVEALED THERE WERE MULTIPLE LOW CARTRIDGE ALARMS. THE ISSUE WAS NOT RESOLVED WITH TRAINING. THERE WAS NO PRODUCT MISUSE. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS COMPLAINT. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE UNRESOLVED LOW CARTRIDGE ALARM ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328572 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR