BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSTRIP GLUCOSE HOSPITAL METER SYSTEM

    MDR report key: 12797732 · Received November 11, 2021

    Report

    Report Number
    1219029-2021-00048
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Date of Event
    October 9, 2021
    Report Date
    December 30, 2021
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    PZI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS CURRENTLY A PENDING INVESTIGATION. THE DEVICE WAS RECEIVED BY THE NOVA SUBSIDIARY ON 11/25/2021. NOVA CORP IS REQUESTING ADDITIONAL INFORMATION, AND FURTHER DETAILS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED AN INCORRECT PATIENT RESULT FOR GLUCOSE WAS RECEIVED WHEN RUNNING A NEONATAL PATIENT SAMPLE ON A STATSTRIP GLUCOSE METER WITH SN (B)(6) USING THE TEST STRIPS OF LOT 0320113309. THIS OCCURRED ON (B)(6)2021. THE METER DID NOT INDICATE THERE WAS A PROBLEM WITH THE SAMPLE IN ANYWAY BEFORE PRODUCING THE RESULT BUT THE NURSE QUESTIONED THE RESULTS BEFORE ANY TREATMENT WAS GIVEN. THERE WAS NO HARM OR ADVERSE TREATMENT DUE TO THE INACCURATE RESULTS. THE METER AND TEST STRIPS WERE NOT RETURNED TO NOVA BIOMEDICAL FOR INVESTIGATION. THE MANUFACTURER RETAINS OF STRIP LOT 0320113309 WERE TESTED ON FIVE STATSTRIP GLUCOSE METERS. ALL TESTS PASSED THE ACCEPTANCE CRITERIA FOR LINEARITY SOLUTIONS AND BLOOD SAMPLES WHEN RAN FOR 10 SETS, ANALYZING FOUR REPLICATES WITH EACH SET. NO DISCREPANCIES WERE OBSERVED BETWEEN BLOOD RESULTS OBTAINED BY THE RETAINED TEST STRIPS WHEN COMPARED TO A REFERENCE ANALYZER. DEVICE HISTORY RECORD (DHR) REVIEWS WERE PERFORMED FOR THE METER AND TEST STRIPS BEING USED AT THE TIME OF THE EVENT BY A QUALITY CONTROL ENGINEER. THE REVIEWS INCLUDED AN ASSESSMENT OF THE PRODUCTION, TESTING, AND RELEASE OF THE METER AND TEST STRIPS. NO ABNORMALITIES OR CONCERNS WERE NOTED, AND THE DHR INDICATED THE RELEASED PRODUCT MET ALL SPECIFICATIONS. THE CONCLUSION OF THE INVESTIGATION IS THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AFTER TESTING THE MANUFACTURER RETAINS OF THE TEST STRIPS. A ROOT CAUSE WAS UNABLE TO BE IDENTIFIED, AND NOVA WILL CONTINUE TO MONITOR FOR RECURRENCE OF SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

    THERE IS CURRENTLY A PENDING INVESTIGATION. NOVA IS REQUESTING ADDITIONAL INFORMATION, AND FURTHER DETAILS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A SITUATION WHERE AN INACCURATE RESULT FOR GLUCOSE WAS RECEIVED WHILE USING A STATSTRIP GLUCOSE METER, SERIAL NUMBER (B)(4) WITH TEST STRIP LOT 0320113309. IT WAS OBSERVED THE GLUCOSE DISCREPANCY FOR THE HEELSTICK TEST WAS OBSERVED FOR A NEONATE PATIENT. THE NURSE QUESTIONED THE RESULTS BEFORE ANY TREATMENT WAS GIVEN. AN ADDITIONAL SAMPLE WAS RUN ACROSS THE METER AND CONFIRMED THE INITIAL RESULTS WERE INCORRECT. NO PATIENT HARM OR ADVERSE TREATMENT DUE TO THE INACCURATE RESULTS WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1691136 STATSTRIP GLUCOSE HOSPITAL METER SYSTEM GLUCOSE TEST SYSTEM PZI NOVA BIOMEDICAL CORP. 1.86

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Female