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

Model Number 1.75

Device Problem Patient Data Problem (3197)

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

Event Date 12/28/2021

Event Type  malfunction  

Manufacturer Narrative

There is currently a pending investigation.Nova is requesting additional information and further details will be provided in a supplemental report.

Event Description

The customer reports that a statstrip meter scanned a patient armband incorrectly.When one patient was scanned a different patient's data appeared.After a rescan the correct patient's information appeared so the meter's serial number was not taken note of.There was no patient harm or intervention reported.

Manufacturer Narrative

Nova initiated an investigation into this meter mis-scan.By requesting, the patient armbands in question.The customer sent sample armbands.And they were graded using a barcode verifier.The quality of the armbands was very low.And it was concluded, that the mis-scan was caused by the poor quality of the armbands.The customer is reviewing their printers and settings, but the nova meter performed as it should.

• Brand Name: NOVA STATSTRIP HOSPITAL METER SYSTEM
• Type of Device: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02453 9141
• Manufacturer (Section G): NOVA BIOMEDICAL CORP.; 200 prospect street; waltham MA 02453 9141
• Manufacturer Contact: katrina thorne gates ; 200 prospect street; waltham, MA 02453-9141 ; 7816473700
• MDR Report Key: 13359388
• MDR Text Key: 287129732
• Report Number: 1219029-2022-00006
• Device Sequence Number: 1
• Product Code: PZI
• UDI-Device Identifier: 00385480533980
• UDI-Public: 00385480533980
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K181043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1.75
• Device Catalogue Number: 53398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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