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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 54794
Device Problem Patient Data Problem (3197)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/04/2019
Event Type  malfunction  
Manufacturer Narrative
No patient impact or adverse event reported.Investigation is on-going, patient barcode samples and statstrip meter returned to nova for evaluation.
 
Event Description
Nova statstrip hospital meter mis-scanned patient barcode id (b)(6) and reported glucose test result under the wrong patient id.
 
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Brand Name
STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
Type of Device
GLUCOSE TEST SYSTEM
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 Key8935506
MDR Text Key177133878
Report Number1219029-2019-00042
Device Sequence Number1
Product Code PZI
UDI-Device Identifier00385480547901
UDI-Public00385480547901
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K181043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number54794
Device Catalogue Number54790
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2019
Date Manufacturer Received08/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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