BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6047585 · Received October 21, 2016

    Report

    Report Number
    2531779-2016-29362
    Event Type
    Injury
    Date Received
    October 21, 2016
    Report Date
    September 28, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION: 12/13/2016. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/17/2016 WITH THE FOLLOWING FINDINGS: THE BLACK BOX SHOWS LOSS OF PRIME WARNING ASSOCIATED WITH A LOW NON-ZERO FORCE ON (B)(6) 2016, 06:28; DELIVERIES RESUMED AT 06:31. THE LOSS OF PRIME OBSERVED ON (B)(6) 2016, 06:51 IS RELATED TO A CARTRIDGE CHANGE. A 24 HR DURATION TEST WAS SUCCESSFULLY COMPLETED WITH NO LOSS OF PRIME WARNINGS BEING DUPLICATED. THE PUMP IS DETECTING THE CORRECT FORCE. THE TDD¿S ADD UP CORRECTLY AND REFLECT THE USERS PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING ACCURATELY AND WITHIN RANGE. REMOVED PUMP COVER; FORCE SENSOR PINS SEATED AND SOLDER CONNECTIONS INTACT. NO EVIDENCE OF CONTAMINATION OR CRACKED FORCE SENSOR TRACES. NO EVIDENCE OF INTERNAL MOISTURE WAS FOUND. UNIDENTIFIED FORCE LOW OBSERVED IN THE BLACK BOX, FORCE SENSOR CALIBRATION IN SPEC. UNABLE TO PERFORM A 10U AUDIO BOLUS DUE TO MISSING AUDIO BOLUS BUTTON COVER. 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) 2016, THE REPORTER CONTACTED ANIMAS, ALLEGING A PRIME ISSUE. THE REPORTER STATED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF OVER 400 MG/DL WITH POLYDIPSIA AND MODERATE KETONES. THE PATIENT DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE CARE OF DIABETES MANAGEMENT. CUSTOMER SUPPORT (CS) COMPLETED TROUBLESHOOTING AND THE REPORTER STATED THAT WHEN THEY GO TO CHANGE OUT THE INFUSION SET AND GO TO PRIME/REWIND SCREEN, THE PRIME BOX ISN'T SHADED IN FROM WHEN THEY DID A PREVIOUS REWIND, LOAD AND PRIME. TROUBLESHOOTING ALSO REVEALED THAT THE PUMP IS NOT PRIMING TUBING DURING LOAD STEP. THIS REPORT IS BEING MADE DUE TO THE BG EXCURSION THE PATIENT EXPERIENCED DUE TO AN ALLEGED PRIME ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699180 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Life Threatening