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

Model Number 54794

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/01/2020

Event Type  malfunction  

Manufacturer Narrative

Udi: (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, this report is being submitted to the fda under 54790 and the subsequent report to health (b)(6) will reflect 54794.The customer reported that there was a barcode misread on a statstrip meter.The facility reported that the meter scanned a patient barcode in the emergency department, however was unsuccessful in obtaining accurate details of the discrepant read.The customer stated that the information was detained in their system and they were unable to determine who the patient was and unable to obtain the armband.The facility is continuing to utilize the meter, therefore; no sample was returned to nova for evaluation.There was no reported patient harm or intervention.A device history record (dhr) review for the analyzer was performed by the investigator.The review included an assessment of the production, testing, and release of the products.No abnormalities or concerns were observed; the dhrs indicated that the released product met all specifications.Previously opened and investigated incidents from the customer facility determined that 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, that 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 barcode misread on a statstrip meter.The facility reported that the meter scanned a patient barcode in the emergency department, however was unsuccessful in obtaining accurate details of the discrepant read.The customer stated that the information was detained in their system and they were unable to determine who the patient was and unable to obtain the armband.The facility is continuing to utilize the meter, therefore; no sample was returned to nova for evaluation.There was no reported patient harm or intervention.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• 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: jesus matos ; 200 prospect street; waltham, MA 02454-9141 ; 7816473700
• MDR Report Key: 10985011
• MDR Text Key: 252270120
• Report Number: 1219029-2020-00052
• Device Sequence Number: 1
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (y/n): Y
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 54794
• Device Catalogue Number: 54790
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2018
• 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