BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2823163 · Received November 7, 2012

    Report

    Report Number
    2531779-2012-13249
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 9, 2012
    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 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION 01/29/2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: EVALUATION REVEALED THAT A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED ON THE PUMP. AND THE PUMP PASSED FLOW ACCURACY TEST AND FOUND TO BE DELIVERY WITHIN THE REQUIRED SPECIFICATIONS. THERE WAS NO DEFECT FOUND.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT'S MOTHER CONTACTED ANIMAS TO REPORT THERE WAS A BLURRY SPOT IN THE MIDDLE OF THE PUMP'S DISPLAY SCREEN. THE REPORTER CLAIMED IT HAD BEEN THERE FOR "SOMETIME." AT THE TIME OF THE CALL TO CUSTOMER SUPPORT, THE PATIENT'S MOTHER REPORTED THAT A FEW DAYS PRIOR SHE GAVE THE PATIENT TOO MUCH INSULIN BECAUSE SHE WAS UNABLE TO REACH THE DISPLAY CORRECTLY. THE REPORTER STATED SHE DELIVERED 4.65 UNITS OF INSULIN INSTEAD OF 4.25 UNITS. AT AN UNSPECIFIED TIME AFTER ADMINISTERING THE INSULIN, THE PATIENT'S MOTHER CLAIMED THE PATIENT BECAME VERY DIZZY. WHEN SHE TESTED HIS BLOOD GLUCOSE IT WAS "45 MG/DL." IN RESPONSE TO THE PATIENT'S LOW BLOOD GLUCOSE, THE REPORTER STATED SHE TREATED THE PATIENT WITH APPLE JUICE. AT THE TIME OF TROUBLESHOOTING, THE PATIENT'S MOTHER DENIED ANY TRAUMA OR EVIDENCE OF MOISTURE IN THE PUMP. THE REPORTER CLAIMED SHE WAS UNAWARE OF HOW THE SPOT APPEARED ON THE DISPLAY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE REPORTER ACCIDENTALLY ADMINISTERED THE INCORRECT AMOUNT OF INSULIN DUE TO THE DISPLAY ISSUE. THE PATIENT'S ALLEGED HYPOGLYCEMIA CAN BE ATTRIBUTED TO USE ERROR, SINCE THE REPORTER KEPT THE PATIENT ON THE PUMP DESPITE BEING AWARE OF THE DISPLAY 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 12 YR Life Threatening| R