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

Model Number	54794
Medical Device Problem Code	Patient Data Problem (3197)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer is located in (b)(6) where the meter part number is 54794.As the manufacturer, a similar device part number for the us to report is 54790.Therefore, this report is being submitted to the fda under (b)(4) and the subsequent report to health (b)(6) will reflect 54794.There was no report of patient harm or any intervention required.A device history record (dhr) review has been requested.Nova is requesting additional information, and further details will be provided in a supplemental report.
Event or Problem Description
The customer reported an incorrect patient account number shown when scanned by the statstrip (1.86) meter.This occurred on (b)(6) 2021.The meter read a 4 as a 6 erroneously.The customer states they are unaware of any patient harm from the barcode misread and will not be returning the meter as it is currently in use at the facility.
Additional Manufacturer Narrative
Additional information: b4, g6, h2, h10.An investigation has been initiated and is still pending.Further details will be provided in an additional supplemental report when they become available.
Additional Manufacturer Narrative
Additional information: a1, b4, g3, g6, g8, h2, h4, h6, h10.Udi: (b)(4) the customer reported an incorrect account number shown when scanned by the statstrip (1.86 meter sn (b)(6).This occurred on (b)(6), 2021.The meter scanned a patient identification number as (b)(6) when the actual number was (b)(6).The customer states they are unaware of any patient harm from the barcode misread and will not be returning the meter as it is currently in use at the facility.No materials were returned for investigation and no further evaluation was possible.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 -39 symbology.Code-39 is no longer industry standard and has a higher substitution failure rate than code-128 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 from a 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.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect st; waltham MA 02454 9141
• MDR Report Key: 11519966
• Report Number: 1219029-2021-00012
• Device Sequence Number: 4881782
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2021

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: 54794
• Device Catalogue Number: 54790
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 03/12/2021; 04/14/2021
• Initial Report FDA Received Date: 03/18/2021
• Supplement Report FDA Received Date: 04/12/2021; 05/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1