BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARE TOUCH

    MDR report key: 16728937 · Received April 12, 2023

    Report

    Report Number
    3016774562-2023-00745
    Event Type
    Injury
    Date Received
    April 12, 2023
    Report Date
    October 4, 2023
    Manufacturer
    TIANJIN EMPECS MEDICAL DEVICE CO., LTD.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT: LIMITED DATA AVAILABLE. I PURCHASED A CARETOUCH A COUPLE WEEKS AGO AND ORDERED A CONTROL SOLUTION. THE CONTROL SOLUTION ARRIVED TODAY AND IT REPEATEDLY FAILS QA FOR THE LEVEL 2 SOLUTION. THE RANGE ON THE STRIPS IS (CODE A01 LOT AWD07H1A1 EXP 2024-04-06) L2: 68-92 L3 216-293,BUT 4 L2 TESTS YIELDED RESULTS OF 64, 67, 66, 66. THE LEVEL 3 SAMPLE REPORTED AS 221 AND 234. I PURCHASED THROUGH AMAZON AND THEY PROVIDED A REFUND FOR THE ISSUE, BUT I RATHER HAVE THE METER WORKING AND REVERSE THE REFUND FROM THE SELLER AND I WANTED TO GIVE YOU AN OPPORTUNITY TO RESOLVE THE ISSUE. THE CONTROL SOLUTION IS LOT 1AR2A091AR3A07, IT EXPIRES IN 231114.

    Description of Event or Problem · 0

    CUSTOMER COMPLAINT - LIMITED DATA AVAILABLE . THE CUSTOMER STATED THAT THEY WERE RECIEVING INACCUATE READINGS WITH THEIR BLOOD GLUCOSE MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306109 CARE TOUCH BLOOD GLUCOSE MONITOR KIT NBW TIANJIN EMPECS MEDICAL DEVICE CO., LTD. CT210 1AR2A091AR3A07, AWD07H1A1

    Patients

    Seq Age Sex Outcome Treatment
    1 Male