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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVA BIOMEDICAL CORPORATION STAT STRIP XPRESS GLU TEST STRIPS; GLUCOSE OXIDASE, GLUCOSE
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NOVA BIOMEDICAL CORPORATION STAT STRIP XPRESS GLU TEST STRIPS; GLUCOSE OXIDASE, GLUCOSE Back to Search Results
Lot Number 0323121249
Patient Problem Irritability (2421)
Event Date 10/11/2023
Event Type  malfunction  
Event Description
Patient blood glucose at 1616 was 64.Hypoglycemia protocol not ordered; team paged requesting protocol to be ordered.Patient refusing po intake, 25mls of d50 given per protocol.Recheck after 15 min was 24.Patient completely alert, even agitated during cares.Team paged.Second dose of d50 given.Continuous d5ns initiated per new order.Bg (blood glucose) continued to drop with rechecks, glucometer showed a bg of 27 and then 11.Attempted again with new test strips, bg was 99.Concern that the test strips for the glucometer are defective.Rn believes that she gave the malfunctioning bottle of test strips to unit leadership so that they could not be used again/follow up could be done.However, she states that in the chaos of dealing with the bg issue she may have thrown the defective strips in the garbage and set aside the test strips that were working.
 
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Brand Name
STAT STRIP XPRESS GLU TEST STRIPS
Type of Device
GLUCOSE OXIDASE, GLUCOSE
Manufacturer (Section D)
NOVA BIOMEDICAL CORPORATION
200 prospect st
waltham MA 02454
MDR Report Key18282410
MDR Text Key329938848
Report Number18282410
Device Sequence Number1
Product Code CGA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Lot Number0323121249
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/21/2023
Event Location Hospital
Date Report to Manufacturer12/07/2023
Type of Device Usage Unknown
Patient Sequence Number1
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