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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP STAT SENSOR CREAT-TEST STRIPS STATSENSOR

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NOVA BIOMEDICAL CORP STAT SENSOR CREAT-TEST STRIPS STATSENSOR Back to Search Results
Model Number 43370
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/13/2020
Event Type  malfunction  
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 Description
The customer reports discrepant creatinine results. The patient did not have a pre-scan intravenous hydration done and was retested. There was no patient injury, harm, or additional treatment provided.
 
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Brand NameSTAT SENSOR CREAT-TEST STRIPS
Type of DeviceSTATSENSOR
Manufacturer (Section D)
NOVA BIOMEDICAL CORP
200 prospect street
waltham, ma
Manufacturer Contact
tracy turcotte
200 prospect street
waltham, ma 
6473700132
MDR Report Key10082688
MDR Text Key199545763
Report Number1219029-2020-00037
Device Sequence Number1
Product Code CGL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K171059
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup,Followup
Report Date 05/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number43370
Device Catalogue Number43370
Device Lot Number4920104129
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/03/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/24/2020
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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