BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STATSTRIP GLUCOSE HOSPITAL METER

    MDR report key: 12674384 · Received October 21, 2021

    Report

    Report Number
    1219029-2021-00042
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 21, 2021
    Report Date
    January 12, 2022
    Manufacturer
    NOVA BIOMEDICAL CORP.
    Product Code
    PZI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED A POWER ISSUE WAS OBSERVED WHILE USING A NOVA BIOMEDICAL STATSTRIP GLUCOSE METER WITH SN (B)(6). THE DEVICE LOST POWER AFTER DRAWING A SAMPLE FROM A PEDIATRIC PATIENT. DUE TO THE POWER LOSS, IT WAS NECESSARY TO DRAW AN ADDITIONAL SAMPLE FROM THE PATIENT IN ORDER TO MEASURE THE GLUCOSE VALUES. THIS OCCURRED ON (B)(6) 2021. NO ADDITIONAL DELAYS IN TREATMENT WERE REPORTED. THE METER AND BATTERY WERE NOT RETURNED TO NOVA BIOMEDICAL FOR INVESTIGATION. HOWEVER, THE CUSTOMER DID RETURN A DIFFERENT METER EXHIBITING SIMILAR PROBLEMS. THIS METER WAS TESTED USING BATTERIES RETAINED BY THE MANUFACTURER, PERFORMING A DROP TEST FROM A HEIGHT OF ONE FOOT AND A BOUNCE TEST WHICH INCLUDING LIFTING THE BOTTOM OF THE METER FROM A SURFACE AND DROPPING IT DOWN, ALLOWING IT TO BOUNCE. AFTER PERFORMING THESE TESTS, THE REPORTED PROBLEM COULD NOT BE REPRODUCED. DEVICE HISTORY RECORD (DHR) REVIEWS WERE PERFORMED FOR THE METER 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 RETURNED CUSTOMER METER. A ROOT CAUSE WAS UNABLE TO BE IDENTIFIED. WHILE THE REPORTED ISSUE WAS NOT REPRODUCED ON THE RETURNED METER, NOVA BIOMEDICAL IS WORKING ON IMPROVEMENTS TO THE METER'S BATTERY HOUSING. A NEW, SLIGHTLY ELONGATED DESIGN HAS ALREADY UNDERGONE INITIAL TESTING AND QUALIFICATION AND FURTHER TESTING IS BEING COMPLETED. NOVA WILL CONTINUE TO MONITOR FOR RECURRENCE OF SIMILAR EVENTS.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    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 · 1

    NOVA BIOMEDICAL (NOVA) WAS MADE AWARE OF A POTENTIAL ISSUE REGARDING THE LOSS OF POWER WHILE USING A STATSTRIP GLUCOSE METER WITH THE SERIAL NUMBER (B)(4). IT WAS REPORTED THE LOSS IN POWER CAUSED THE HEALTHCARE PROVIDER TO DRAW A SAMPLE FROM THE PEDIATRIC PATIENT A SECOND TIME, SOMETHING WHICH WOULD NOT HAVE BEEN NECESSARY HAD THE METER NOT LOST POWER. NO OTHER DELAYS IN TREATMENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568218 STATSTRIP GLUCOSE HOSPITAL METER GLUCOSE TEST SYSTEM PZI NOVA BIOMEDICAL CORP. 1.86

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown