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

Model Number 54790

Device Problem Patient Data Problem (3197)

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

Event Date 02/10/2021

Event Type  malfunction  

Manufacturer Narrative

There was no report of patient harm or any intervention required.There currently is a pending investigation.Nova is requesting additional information, and further details will be provided in a supplemental report.

Event Description

The customer reported that they had a patient account number show the wrong number when scanned by the statstrip (1.86) meter.This occurred on (b)(6) all the same patient that was discharged back on (b)(6) 2020.It was also stated that this happened using 2 different meters but within the same unit area.Unfortunately when this was discovered it was on (b)(6) and operators on the floor could not determine which patient armband was used when this incident occurred.The facility provided four meter serial numbers: (b)(4) that were given as potential meters that were located on the floor.The customer states that they are unaware of any potential patient harm from the barcode misread and will not be returning the meters as they are currently in use at the facility.

Manufacturer Narrative

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

Manufacturer Narrative

Udi: (b)(4) the facility reported the meter scanned a patient barcode and registered the scan as a different patient.The initial reporter stated this happened on several different days but was unsure of which meters were used producing the errouneous results.A device history record (dhr) review for the meters indicated was performed.This included an assessment of the production, testing, and release of the products.No abnormalities or concerns were observed; the dhrs indicated the released products met all specifications.With the assistance of nova, it was determined the mis-scans were caused by poor barcode quality which was not a result of or related to the meters in question.This was determined using webscan trucheck barcode verification graders and ten different barcodes.All barcodes received an overall symbol grade of "f", indicating failure in quality and the ability to be correctly read.Nova worked with the customer and a representative from epic to increase the quality of their barcodes to ensure this does not occur again.This required changing the drivers in the printers from pcl to postscript and increasing the length of the barcodes.In test, this resulted in an overall symbol grade of "c" which the representative from epic indicated was due to low toner in the printer.As this will take a few weeks to change throughout the facility, they have also implemented adt for patient validation as a safety measure to ensure no further mis-scans occur without detection.A capa is not required as a result of this investgation because the root cause of the error was determined to be poor barcode quality.Trending will be monitored for this and/or similar complaints.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Type of Device: BLOOD GLUCOSE METER
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect st; waltham MA 02454 9141
• MDR Report Key: 11406135
• MDR Text Key: 264066794
• Report Number: 1219029-2021-00002
• Device Sequence Number: 1
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (y/n): N
• PMA/PMN Number: K181043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2021

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: 54790
• Device Catalogue Number: 54790
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 03/08/2021; 04/20/2021
• Supplement Dates FDA Received: 03/31/2021; 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1