MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. NOVA STATSTRIP HOSPITAL METER SYSTEM; GLUCOSE TEST SYSTEM

Model Number	1.75
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is currently a pending investigation.Nova is requesting additional information and further details will be provided in a supplemental report.
Event or Problem Description
The customer reports that a statstrip meter scanned a patient armband incorrectly.When one patient was scanned a different patient's data appeared.After a rescan the correct patient's information appeared so the meter's serial number was not taken note of.There was no patient harm or intervention reported.
Additional Manufacturer Narrative
Nova initiated an investigation into this meter mis-scan.By requesting, the patient armbands in question.The customer sent sample armbands.And they were graded using a barcode verifier.The quality of the armbands was very low.And it was concluded, that the mis-scan was caused by the poor quality of the armbands.The customer is reviewing their printers and settings, but the nova meter performed as it should.

• Brand Name: NOVA STATSTRIP HOSPITAL METER SYSTEM
• Common Device Name: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02453 9141
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02453 9141
• Manufacturer Contact: katrina thorne gates ; 200 prospect street; waltham, MA 02453-9141 ; 7816473700
• MDR Report Key: 13359388
• Report Number: 1219029-2022-00006
• Device Sequence Number: 1751806
• Product Code: PZI
• UDI-Device Identifier: 00385480533980
• UDI-Public: 00385480533980
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K181043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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 Number: 1.75
• Device Catalogue Number: 53398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2021
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown