BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3053373 · Received April 11, 2013

    Report

    Report Number
    2531779-2013-04073
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO ANIMAS AND EVALUATED BY PRODUCT ANALYSIS ON 07/25/2013 WITH THE FOLLOWING RESULTS: NO DEFECT WAS FOUND. THE COMPLAINT COULD NOT BE DUPLICATED DURING THE INVESTIGATION. PUMP POWERED ON WITH VIBRATORY AND AUDIBLE SOUNDS. ALL KEYS ARE RESPONSIVE, NO HYPERSENSITIVE KEYS WERE OBSERVED. THE PUMP WAS TESTED ON A 29HR FLOW TEST; THE PUMP PASSED THE REQUIRED TEST AND WAS FOUND TO BE DELIVERING WITHIN THE SPECIFICATION. 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. 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. 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

    ON (B)(6) 2013 THE PATIENT CONTACTED ANIMAS TO TROUBLESHOOT ELEVATED BLOOD GLUCOSE (BG) OF 329MG/DL. DURING TROUBLESHOOTING, THE PATIENT BECAME VERY CONFUSED AND WAS ADVISED TO RE-CHECK HIS BG. THE PATIENT'S BG AFTER BEING ON THE PHONE WITH ANIMAS FOR 10 TO 15 MINUTES WENT DOWN TO 81MG/DL. CUSTOMER TECHNICAL SUPPORT CONTACTED EMERGENCY SERVICES FOR THE PATIENT AND WHEN THE PARAMEDICS ARRIVED THE PATIENT'S BG WAS REPORTEDLY 59MG/DL. THE PATIENT REPORTEDLY WAS INSTRUCTED TO DRINK SODA. THE PATIENT'S WIFE REPORTED THAT THE PATIENT HAS BEEN HAVING LOW BG ISSUES FOR A FEW WEEKS AND THE PATIENT'S HEALTHCARE PROVIDER (HCP) WAS SUPPOSED TO BE MAKING SETTINGS CHANGES. THE PATIENT REPORTEDLY REQUESTED NOT TO BE TAKEN TO THE HOSPITAL AND FOLLOW-UP WITH THE PATIENT INDICATED THAT THE PATIENT'S BG RESOLVED TO 171MG/DL. THE PATIENT DECLINED TROUBLESHOOTING AT THE TIME OF THE REPORTED INCIDENT, STATING THAT HE WANTED HIS HCP TO LOOK AT THE PUMP AT A REGULARLY SCHEDULED APPOINTMENT AND DIDN'T WANT TO TOUCH ANYTHING ON THE PUMP UNTIL IT WAS REVIEWED BY HIS HCP. CUSTOMER TECHNICAL SUPPORT FOLLOWED UP WITH THE PATIENT ON (B)(6) 2013 AND THE PATIENT STATED THAT HE FOLLOWED UP WITH HIS ENDOCRINOLOGIST THE SAME DAY OF THE REPORTED INCIDENT AND BASAL RATES WERE DECREASED. THE PATIENT STATED HE HAS NOT HAD ANY LOW BGS SINCE THE BASAL RATES WERE DECREASED. A REVIEW OF THE PUMP HISTORY FOR (B)(6) 2013 WAS COMPLETED AND THE HISTORIES WERE FOUND TO BE CORRECT. THERE WAS NO INDICATION OR ALLEGATION OF A PUMP MALFUNCTION. THE REPORTED BG ELEVATION DOES NOT MEET CRITERIA FOR A SERIOUS INJURY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPERGLYCEMIA REQUIRING MEDICAL INTERVENTION WHILE ON INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155848 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R