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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP STATSTRIP GLUCOSE METER SYSTEM; BLOOD GLUCOSE METER
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NOVA BIOMEDICAL CORP STATSTRIP GLUCOSE METER SYSTEM; BLOOD GLUCOSE METER Back to Search Results
Model Number 53398
Medical Device Problem Code Imprecise or Erratic Results (4059)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 04/13/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The complaint sample has not returned to nova as of yet; therefore, an evaluation of the device could not be performed.Further investigation is being completed and a supplemental report will be submitted upon completion.
 
Event or Problem Description
The customer reported discrepant patient results.A test was run on (b)(6) on the statstrip 1.75 meter sn: (b)(4) and a flow error occurred.It was rerun and was less than 10, a draw was done and it was 532.The patient was moved to another floor and tested with another meter and received good results.There was no patient harm or medical intervention.
 
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Brand Name
STATSTRIP GLUCOSE METER SYSTEM
Common Device Name
BLOOD GLUCOSE METER
Manufacturer (Section D)
NOVA BIOMEDICAL CORP
200 prospect street
waltham MA 02454 9141
MDR Report Key11809037
Report Number1219029-2021-00020
Device Sequence Number14430473
Product Code PZI
UDI-Device Identifier00385480533980
UDI-Public00385480533980
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
K181043
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number53398
Device Catalogue Number53398
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/13/2021
Initial Report FDA Received Date05/11/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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