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

Model Number 54790

Device Problem Patient Data Problem (3197)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/31/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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, the report is being submitted to the fda under 54790 and the subsequent report to (b)(6) will reflect 54794.The facility reported patient barcode scan error on a patient's identification number.They did not report any patient harm or medical 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 -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.

Event Description

The customer reported that 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 (b)(6) 2021.The customer stated that they were 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
• Type of Device: BLOOD GLUCOSE METER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect street; waltham MA 02454 9141
• Manufacturer (Section G): NOVA BIOMEDICAL; 200 prospect street; waltham MA 02454 9141
• Manufacturer Contact: shalomy mathew ; 200 prospect street; waltham, MA 02454-9141 ; 7816473700
• MDR Report Key: 12796602
• MDR Text Key: 282555879
• Report Number: 1219029-2021-00050
• Device Sequence Number: 1
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K181043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 54790
• Device Catalogue Number: 54794
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1