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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. STATSTRIP GLUCOSE HOSPITAL METER SYSTEM; GLUCOSE TEST SYSTEM
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NOVA BIOMEDICAL CORP. STATSTRIP GLUCOSE HOSPITAL METER SYSTEM; GLUCOSE TEST SYSTEM Back to Search Results
Model Number 42214
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/22/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Investigation in process, meter expected to be returned by customer.Customer noted that two discrepant patient results reported by the first nova statstrip meter were using the last 2 test strips form that vial.Customer also stated that they could not confirm that the strip vial was properly handled.
 
Event or Problem Description
Discrepant glucose results using nova statstrip meter compared to a non-nova meter and a second nova statstrip meter.
 
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Brand Name
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Common Device Name
GLUCOSE TEST SYSTEM
Manufacturer (Section D)
NOVA BIOMEDICAL CORP.
200 prospect st
waltham MA 02454 3465
MDR Report Key8631717
Report Number1219029-2019-00008
Device Sequence Number13934375
Product Code PZI
UDI-Device Identifier10385480422144
UDI-Public10385480422144
Combination Product (Y/N)N
Initial Reporter CountryTC
PMA/510(K) Number
K181043
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 05/22/2019
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
Operator of Device Health Professional
Device Expiration Date12/31/2019
Device Model Number42214
Device Lot Number0317163309
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/29/2019
Initial Report FDA Received Date05/22/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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