BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUATE BLOOD GLUCOSE STRIPS

    MDR report key: 10238045 · Received July 7, 2020

    Report

    Report Number
    3005862821-2020-00037
    Event Type
    Injury
    Date Received
    July 7, 2020
    Date of Event
    May 26, 2020
    Report Date
    June 17, 2020
    Manufacturer
    OK BIOTECH CO., LTD.
    Product Code
    CGA
    PMA / PMN Number
    K162430
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO NON-CONFORMITY WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS OF STRIPS (LOT#: U19100412). STRIPS WERE MANUFACTURED ON 10/04/2019 AND WILL EXPIRE IN 10/2021. BECAUSE THE SUSPECTED STRIPS WERE NOT RETURNED TO OKB, THE RETAINED STRIPS (LOT#: U19100412) FROM OKB'S WAREHOUSE WERE USED TO RE-TEST WITH ONETOUCH METER (CODE: 49) AND CONTROL SOLUTION (LEVEL LOW: BATCH# 8AH1A95, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A15, EXP. BY DEC., 2020). TESTING RESULTS (LEVEL LOW: 46/43; LEVEL HIGH: 259/256) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 30~80; LEVEL HIGH: 230~340), AND DESICCANTS OF STRIP VIAL ARE FUNCTIONAL. THE ROOT CAUSE OF THE COMPLAINT IS UNABLE TO BE VERIFIED WITHOUT THE SUSPECTED STRIPS AND MORE USER'S INFORMATION. THEREFORE, THE MATTER HAS TO BE CLOSED OUT IF NO FURTHER ACTION OR INFORMATION FROM THE USER.

    Description of Event or Problem · 1

    CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 DUE TO HER EQUATE TEST STRIPS GIVING A LOW RESULT. THE CALLER STATED THAT SHE GAVE HER SON INSULIN BASED OFF THE RESULT SHE RECEIVED WHEN SHE TESTED HIS BLOOD GLUCOSE WITH THE EQUATE TEST STRIPS. SHE STATED THAT THIS CAUSED HER TO HAVE TO TAKE HER SON TO THE HOSPITAL. WE HAVE ATTEMPTED TO CONTACT THE CALLER TO OBTAIN MORE INFORMATION AND LEFT MULTIPLE MESSAGES AND THE CALLER HAS NOT CALLED BACK TO PROVIDE US WITH MORE INFORMATION. WE DO NOT HAVE ANY INFORMATION ON THE END-USER. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706648 EQUATE BLOOD GLUCOSE STRIPS BLOOD GLUCOSE TEST STRIPS CGA OK BIOTECH CO., LTD. U19100412

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization