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	04/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is currently a pending investigation.The customer is unsure of the exact meter but has narrowed it down to four possible serial numbers.Those serial numbers are (b)(4).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 responsible meter's serial number was not taken note of.There was no patient harm or intervention reported.
Additional Manufacturer Narrative
The customer provided samples of the armbands that are used at their facility.The armbands/barcodes were graded at nova by a validated scanner and the barcodes graded poorly.It was recommended to the customer to improve their barcode printing.Dhr reviews were performed on the four meters that the customer suspected and there were no abnormalities observed.

• 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: 13505963
• Report Number: 1219029-2022-00008
• Device Sequence Number: 14463043
• Product Code: PZI
• UDI-Device Identifier: 00385480533980
• UDI-Public: 00385480533980
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/14/2022

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: 01/12/2022
• Supplement Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 02/10/2022
• Supplement Report FDA Received Date: 04/14/2022
• 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