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

Model Number 53398

Device Problem Patient Data Problem (3197)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

There was no reported patient harm or intervention.There is currently a pending investigation.A request has been sent to the customer obtain meters and barcode or sample of a test barcode for verification of 1-d versus 2-d barcodes.Additional information and further details will be provided in a supplemental report.

Event Description

A customer reported that gluc conn meters (1.75) mis-scanning 1d bar showing incorrect patient id's.The account has 1 & 2 d bar codes on patients wrists.There has been no report of patient harm or adverse event.

Manufacturer Narrative

Additional and corrected information: b4, d9, g6, h1, h2, h3, h10.An investigation has been initiated and is currently pending.Further details will be provided in an additional supplemental report when they become available.

Manufacturer Narrative

An investigation has been initiated and is currently pending.Further details will be provided in an additional supplemental report when they become available.

Manufacturer Narrative

Udi: (b)(4).The customer reported an incorrect account number shown when scanned by the statstrip 1.75 meter (b)(6).This occurred on (b)(6) 2021.The meter scanned a patient identification number as and accessed the incorrect patient information.The customer states there was not patient harm as a result of this.The meter was returned to nova biomedical corp.For investigation.The scanner window was free of damage or debris and seemed to not effect the scanner on the meter.An unused barcode was provided by the customer which was scanned fifty times without producing an error.The customer did not return one of the malfunctioning barcodes for investigation.The barcode was put through a lvs-9570 barcode verifier which gave the barcode a grade of "f" for decodability and modulation.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 with similarily-graded barcodes determined the root cause for the patient misreads to be 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, it is 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.A corrective and preventative action (capa) is not required as a result of this investigation because the root cause of the reported issue was determined to be poor barcode quality.This is report 2 of 2.

• Brand Name: NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Type of Device: BLOOD GLUCOSE METER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect street; waltham MA 02454 9141
• MDR Report Key: 11507503
• MDR Text Key: 243844468
• Report Number: 1219029-2021-00008
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00385480533980
• UDI-Public: 00385480533980
• Combination Product (y/n): N
• PMA/PMN Number: K063821
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/10/2021

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
• Device Operator: Health Professional
• Device Model Number: 53398
• Device Catalogue Number: 53398
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/18/2021
• Initial Date FDA Received: 03/17/2021
• Supplement Dates Manufacturer Received: 02/18/2021; 02/18/2021; 06/10/2021
• Supplement Dates FDA Received: 04/14/2021; 05/13/2021; 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1