BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2801939 · Received October 23, 2012

    Report

    Report Number
    2531779-2012-12661
    Event Type
    Injury
    Date Received
    October 23, 2012
    Report Date
    September 29, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 12/15/2015. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 12/03/2015 WITH THE FOLLOWING FINDINGS: REPORTED DATE FROM (B)(6) 2012 IS OVERWRITTEN, LAST BASAL DELIVERY WAS ON (B)(6) 2015@1:53PM. A 12HR POWER INTERRUPTION ON (B)(6) 2015 AND TIME CHANGE TO WRONG SETTING AFTER A RESET WHICH LEAD TO TDD TO APPEAR INACCURATE. ¿EZ-PRIME¿ STEPS WERE PERFORMED CORRECTLY, NO DELIVERY INTERRUPTION OR ANY EAW OCCURRED DURING THE INVESTIGATION, THE PUMP REFLECTED 24U AFTER A 24HR ON 1/HR BASAL PROGRAM; THE PRODUCT PERFORMS WITHIN SPECIFICATIONS. INVESTIGATORS WERE UNABLE TO DUPLICATE ¿INACCURATE DELIVERY¿. 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. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT CONTACTED ANIMAS TO REPORT ELEVATED BLOOD GLUCOSE (BG) EXCURSIONS FOR THE APPROXIMATE PAST WEEK. THE PATIENT CLAIMED HER BG VALUES HAD BEEN IN THE 400 AND 500'S MG/DL RANGE. THE PATIENT STATED SHE FELT TIRED WITH THE HIGH BG'S; HOWEVER, DENIED DEVELOPING ANY OTHER SYMPTOMS. THE PATIENT INFORMED CUSTOMER SUPPORT THAT HER NORMAL BG IS 80-110 MG/DL. THE PATIENT REPORTED CORRECTING THE HIGH BG WITH INJECTIONS. AT THE TIME OF TROUBLESHOOTING, THE PATIENT DENIED ANY ISSUES THE CANNULAS OR TUBING. SHE CONFIRMED ALL PUMP SETTINGS WERE CORRECT. HOWEVER AFTER REVIEW OF PUMP SETTINGS AND HISTORY, CUSTOMER SUPPORT DISCOVERED THAT THE PATIENT WAS NOT PRIMING TUBING AND NEEDLE CORRECTLY. IT WAS NOTED THAT THE PATIENT WAS NOT USING THE CONTACT DETACH CORRECTLY CAUSING THE PATIENT NOT TO RECEIVE INSULIN FOR HOURS WHEN CHANGING SITE/SET OR JUST CHANGING THE SITE. CUSTOMER SUPPORT WALKED THE PATIENT THROUGH PROPER TECHNIQUE FOR CONNECTING AND DISCONNECTING AND PRIMING WITH INSERTION SET NOT IN BODY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY OBTAINED BG READINGS EQUAL TO OR GREATER THAN 500 MG/DL WHILE ON INSULIN PUMP THERAPY. BASED ON THE INFORMATION PROVIDED, THE ALLEGED HYPERGLYCEMIA CAN BE ATTRIBUTED TO USE ERROR SINCE THE PATIENT DID NOT FOLLOW INSTRUCTIONS FOR PRIMING TUBING AND FILLING CANNULA AS INSTRUCTED IN THE INSTRUCTIONS FOR USE.

    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 63 YR Life Threatening| R