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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM; ELECTRODE, ION BASED, ENZYMATIC, CREATININE

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NOVA BIOMEDICAL CORP. NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM; ELECTRODE, ION BASED, ENZYMATIC, CREATININE Back to Search Results
Model Number 43370
Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/24/2019
Event Type  malfunction  
Manufacturer Narrative
Investigation ongoing.Evaluation of retain strips and dhr reviews for both the meter and test strip batch to be completed.Qc results before and after the reported incident were in range, meter was not returned for investigation.The healthcare professional reported that the patient was a difficult stick and the fingerstick was attempted twice.
 
Event Description
Discrepant creatinine results using nova statsensor meter.No adverse event was reported.
 
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Brand Name
NOVA STATSENSOR CREATININE HOSPITAL METER SYSTEM
Type of Device
ELECTRODE, ION BASED, ENZYMATIC, CREATININE
Manufacturer (Section D)
NOVA BIOMEDICAL CORP.
200 prospect st
waltham MA 02454 3465
Manufacturer (Section G)
NOVA BIOMEDICAL CORP.
200 prospect st
waltham MA 02454 3465
Manufacturer Contact
taylor ward
200 prospect st
waltham, MA 02454-3465
7816473700
MDR Report Key8804722
MDR Text Key151909946
Report Number1219029-2019-00034
Device Sequence Number1
Product Code CGL
UDI-Device Identifier10385480433706
UDI-Public10385480433706
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K171059
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other
Type of Report Initial
Report Date 07/18/2019
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
Device Operator Health Professional
Device Expiration Date11/29/2019
Device Model Number43370
Device Lot Number4918333129
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/24/2019
Initial Date FDA Received07/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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