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

Model Number GLU TEST STRIP

Device Problem Failure to Sense (1559)

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

Event Date 09/21/2021

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

Customer indicated that when measuring the glucose for the patient, the meter could not provide a result after the sample was applied.The meter did recognize when the strip was inserted.Sample was applied to the strip and the meter did not progress to the analyzing countdown.Another strip was used and was able to obtain a result.It was not indicated whether the new strip was from a different lot or same lot.Customer was using test strip lot 0320153249.There was no adverse action indicated due to the meter.

Manufacturer Narrative

The customer complaint could not be reproduced.Evaluation of retains from the same lot was performed.All results were accurate, the reported issue was not observed.A dhr review was performed.No issue were identified, the product met all specification prior to release.Nova biomedical will continue to monitor for recurrence as part of our post market surveillance program.

• Brand Name: NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM
• Type of Device: GLUCOSE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP; 200 prospect street; waltham MA 02454 9141
• Manufacturer (Section G): NOVA BIOMEDICAL CORP; 200 prospect street; waltham MA 02454 9141
• Manufacturer Contact: shalomy mathew ; 200 prospect street; waltham, MA 02454-9141 ; 7816473700
• MDR Report Key: 14147590
• MDR Text Key: 298891913
• Report Number: 1219029-2022-00025
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 10385480422144
• UDI-Public: 10385480422144
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K063821
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2022

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 Expiration Date: 06/01/2022
• Device Model Number: GLU TEST STRIP
• Device Catalogue Number: 42214
• Device Lot Number: 0320153249
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 03/21/2022
• Supplement Dates FDA Received: 05/18/2022
• 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: Initial
• Patient Sequence Number: 1