BEUDAMED
    FDA Adverse Event Death Summary report: N

    STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

    MDR report key: 17980167 · Received October 20, 2023

    Report

    Report Number
    1219029-2023-00002
    Event Type
    Death
    Date Received
    October 20, 2023
    Date of Event
    August 21, 2023
    Report Date
    October 20, 2023
    Manufacturer
    NOVA BIOMEDICAL CORPORATION
    Product Code
    PZI
    UDI-DI
    00385480547901
    PMA / PMN Number
    K181043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (E1) THE NAME OF THE INITIAL REPORTER WAS NOT PROVIDED. PATIENT WAS GIVEN DOSES OF VITAGEN (GLUCOSE) BASED ON METER RESULTS. PATIENT AMINISTERD VASOPRESSOR PITRESSIN AND ADRENALINE WHILE IN THE ER. CAPILLARY SAMPLE TESTING IS CONTRAINDICATED FOR PATIENTS WITH COMPROMISED CAPILLARY BLOOD FLOW. ALL SAMPLES TESTED ON THE STATSTRIP GLUCOSE HOSPITAL METER SYSTEM WERE CAPILLARY SAMPLES. INSTRUCTION FOR USE MANUAL: CAUTION: CAPILLARY BLOOD GLUCOSE TESTING MAY NOT BE APPROPRIATE FOR PERSONS WITH DECREASED PERIPHERAL BLOOD FLOW, AS IT MAY NOT REFLECT THE TRUE PHYSIOLOGICAL STATE. EXAMPLES INCLUDE, BUT ARE NOT LIMITED TO, SEVER HYPOTENSION, SHOCK, HYPEROSMOLAR-HYPERGLYCEMIA (WITH OR WITHOUT KETOSIS) AND SEVERE DEHYDRATION. INFORMATION PROVIDED BY THE HOSPITAL INDICATES THE PATIENT CONDITION WAS 'BAD' WHEN SENT TO THE HOSPITAL. "THE DOCTOR THINKS THE PATIENT PASSED AWAY NOT NECESSARILY RELATED TO THE GLUCOSE TREATMENT". THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED NOR REPLICATED. THE METER AND TEST STRIPS IN QUESTION WERE NOT RETURNED FOR EVALUATION. THIS IS FURTHER SUPPORTED BY THE CONFIRMATION FROM THE HOSPITAL THAT THE METER AND GLUCOSE TEST STRIPS PASSED ALL QC PRIOR TO AND AFTER THE REPORTED INCIDENT. THE METER SYSTEM REMAINED IN SERVICE AT THE FACILITY. RETAINED STATSTRIP TEST STRIPS FROM THE REPORTED LOT WERE TEST MET THE PERFORMANCE ACCEPTANCE CRITERIA FOR LINEARITY CONTROLS AND ALSO FOR WHOLE BLOOD SPECIMENS. NO DISCREPANT RESULTS WERE OBSERVED. A DHR REVIEW WAS PERFORMED FOR THE IDENTFIED METER AND GLUCOSE STRIP LOT. NO ABNORMALITIES OR CONCERNS WERE OBSERVED. THE DHR INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. NO FURTHER ACTION IS RECOMMENDED AT THIS TIME. NOVA BIOMEDICAL WILL CONTINUE TO MONITOR FOR THIS OR SIMILAR EVENTS.

    Description of Event or Problem · 0

    "THE PATIENT GLUCOSE TESTED AS 12 MG/DL AT 11:33. AFTER GIVING THE VITAGEN (GLUCOSE), A VENOUS SAMPLE WAS DRAWN AND RUN ON THE CLINICAL ANALYZER. THE RESULT WAS TESTED AS 881 MG/DL ON CLINICAL ANALYZER (11:59-12:32). WHILE THE RESULTS STILL KEEPS LOW AS 13 MG/DL ON STATSTRIP GLUCOSE (TEST TIME: 12:14). THE METER REPORTS DIFFERENTLY COMPARING TO THE LAB SYSTEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1995949 STATSTRIP GLUCOSE HOSPITAL METER SYSTEM BLOOD GLUCOSE MONITOR FOR NEAR-PATIENT TESTING PZI NOVA BIOMEDICAL CORPORATION 0322094309 00385480547901

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death