BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2260268 · Received September 22, 2011

    Report

    Report Number
    2531779-2011-07010
    Event Type
    Malfunction
    Date Received
    September 22, 2011
    Report Date
    August 26, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    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. (B)(6).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: NO DATA IN THE BLACK BOX FROM THE TIME OF THE REPORTED POWER ISSUE DUE TO CONTINUED PATIENT USE. NO POWER ISSUES WERE OBSERVED IN THE BLACK BOX. NO ACTIVITY OUTSIDE NORMAL USE OBSERVED IN THE BLACK BOX OR DOWNLOAD HISTORY. NO DAMAGE WAS FOUND TO THE BATTERY CAP OR BATTERY COMPARTMENT. THE BATTERY CAP WAS ABLE TO ATTACH SECURELY TO THE PUMP. A BATTERY CAP CONTACT TEST WAS PERFORMED; NO BATTERY CAP CONNECTION DEFECTS WERE OBSERVED. PUMP POWERS ON NORMAL WITH NO ALARMS. THE PUMP WAS EXERCISED FOR 24 HRS WITH NO ALARMS OR POWER ISSUES OCCURRING. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE POWER CIRCUIT. UNRELATED TO THE COMPLAINT, THE KEYPAD WAS FOUND TO BE TORN.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT THE ANIMAS PUMP HAS LOST POWER TWICE. THE ANIMAS PUMP WAS NOT AVAILABLE TO BE TROUBLESHOOT AT THE TIME OF THE CALL. DURING A FOLLOW-UP, THE REPORTER INDICATED THAT THE POWER ISSUE HAS NOT BEEN AN ISSUE SINCE THE INITIAL PHONE ON (B)(6) 2011. NO OTHER INFORMATION WAS OBTAINED IN REGARDS TO THE TROUBLESHOOTING THE POWER ISSUE. THE PRODUCT WAS SENT BACK FOR INVESTIGATION DUE TO A KEYPAD ISSUE. THERE WAS NO REPORT OF ANY PATIENT IMPACT ASSOCIATED WITH THE COMPLAINT. THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION DUE TO THE ALLEGE POWER ISSUE.

    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 13 YR