BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2102700 · Received May 25, 2011

    Report

    Report Number
    2531779-2011-03685
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 28, 2011
    Report Date
    April 29, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION FOLLOW-UP #2 SUBMITTED (B)(4) 2013: THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING RESULTS: NO INSULIN DELIVERY DEFECT WAS FOUND. NO DATA IN BLACK BOX OR DOWNLOAD HISTORIES FROM TIME OF REPORTED HIGH BGS DUE TO CONTINUED USE.. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT THE PATIENT EXPERIENCED A BLOOD GLUCOSE VALUE (BG) OF 524 MG/DL WITH KETONES ON (B)(6) 2011. THE FAMILY MEMBER NOTED THAT THE PATIENT HAD BEEN SICK ON (B)(6) 2011 WITH A SORE THROAT AND A FEVER. SHE STATED THAT CORRECTIONS FOR THE HIGH BG WERE GIVEN VIA SYRINGE, AND THE PATIENT'S BG 4 HOURS LATER WAS 304MG/DL. SHE STATED THAT A BOLUS WAS GIVEN VIA THE PUMP TWICE, BUT THE BG DID NOT RESPOND FURTHER AND REMAINED AT 295 MG/DL. THE FAMILY MEMBER REPORTED THAT THE SITE/SET WAS CHANGED ON (B)(6) 2011, AND THERE WAS BLOOD FOUND IN THE CANNULA. SHE STATED THAT A CORRECTION BOLUS WAS GIVEN VIA THE PUMP AFTER THE SITE/SET CHANGE, AND THE PATIENT'S BG RESOLVED TO 124 MG/DL. A REVIEW OF THE PUMP HISTORY WITH ANIMAS CUSTOMER SUPPORT (CS) FOUND THAT THE BOLUS THAT WAS PROGRAMMED FOR DINNER (B)(6) 2011 WAS CANCELLED. THE PATIENT HAS CONTINUED USING THE PUMP WITHOUT FURTHER REPORTED INCIDENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING THE PUMP.

    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 3 YR Required Intervention