BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3092445 · Received May 3, 2013

    Report

    Report Number
    2531779-2013-05869
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 25, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 (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 BLACK BOX SHOWED MULTIPLE DELIVERY INTERRUPTIONS RELATED TO OCCLUSION ALARMS OCCURRING ON (B)(6) 2013 INCLUDING AN OCCLUSION OCCURRING AT 03:02, DELIVERIES WERE NOT RESUMED UNTIL 06:20, AND AT 18:48, DELIVERIES WERE NOT RESUMED UNTIL 20:59. THE BLACK BOX ALSO SHOWED DELIVERY INTERRUPT RELATED TO AN OCCLUSION OCCURRING ON (B)(6) 2013 AT 05:31 DELIVERIES WERE NOT RESUMED UNTIL 07:40. DURING TESTING AUDIO AND NORMAL BOLUSES WERE PROGRAMMED AND WERE RECORDED ACCURATELY IN THE PUMP HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. NO PUMP DEFECT WAS FOUND RELATED TO THE EVENT.

    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

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2013, REPORTING THAT THE PATIENT'S BLOOD GLUCOSE (BG) WAS HIGH IN THE 20-30MMOL/L FOR THE LAST WEEK AND A HALF. THE REPORTER STATED THAT THE PATIENT'S BG TODAY AT 7AM WAS HIGH WITH POLYURIA AND MOODINESS. THE REPORTER STATED THAT THE PUMP EMITTED NO PRIME/NO DELIVERY WARNINGS AND LOW BATTERY ALARMS. THE PATIENT HAS DISCONTINUED PUMP AND IS ON ALTERNATE DELIVERY METHOD. THIS REPORT IS BEING MADE DUE TO THE ALLEGED HYPERGLYCEMIC EVENT THAT THE PATIENT EXPERIENCED ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193581 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Life Threatening