MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP STATSTRIP GLUCOSE HOSPITAL METER; BLOOD GLUCOSE METER

Model Number	54790
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).The customer is located in canada where the meter part number is 54794.As the manufacturer, a similar device part number for the us to report is 54790.Therefore, the report is being submitted to the fda under 54790 and the subsequent report to health canada will reflect 54794.The facility reported patient barcode scan error on a patient's identification number.They did not report any patient harm or intervention.The facility is continuing to utilize the meter, therefore; no sample was returned to nova for evaluation.A device history record (dhr) review for the meter was performed.The review included an assessment of the production, testing, and release of the products.No abnormalities or concerns were observed; the dhr indicated the released product met all specifications.Previously opened and investigated incidents from the customer facility determined the root cause for the patient misreads is attributed to the user facility using poor quality 1d barcodes that were printed using code: (b)(4) symbology.Code: (b)(4) is no longer industry standard and has a higher substitution failure rate than code: (b)(4) and much higher than the standard 2d barcodes available.This failure mode does not represent a systemic issue or a failure of the meter to perform as intended.The failure mode is directly related to the quality of the barcode being generated by the customer.The root cause of the misread is most likely due to poor barcode quality.Based on the original investigation, nova suggested to prevent barcode mis-reads in the future, the customer should change froma 1d to a 2d barcode, which would greatly reduce the chances of a barcode misread.Trending will be monitored for this and or similar complaints.
Event or Problem Description
The customer reported there was a bar code scanning error on a patient's identification number while using a stat strip (1.86) meter.The incident occurred on september 15, 2021.The customer states they are unaware of any potential patient harm from the barcode misread and will not be returning the meter as it is currently in use at the facility.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect street; waltham MA 02454 9141
• MDR Report Key: 12542019
• Report Number: 1219029-2021-00041
• Device Sequence Number: 1416176
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: foreign,health professional,u
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

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: 54790
• Device Catalogue Number: 54794
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1