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

Model Number GLU TEST STRIP

Device Problem Erratic Results (4059)

Patient Problem Insufficient Information (4580)

Event Date 02/28/2022

Event Type  malfunction  

Event Description

The customer indicated that their stat strip meter, serial number: (b)(4) gave a lower result compared to another meter.Patient was transferred to pediatrics and tested again.Customer confirmed that the stat strip meter was passing qc.Using test strip lot 0320153249 pn 54515.It was indicated that there was no adverse event due to the meter.

Manufacturer Narrative

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

Manufacturer Narrative

Udi: (b)(4).The complainants alleged deficiency could not be confirmed.The statstrip glucose test strips in question were not returned for evaluation.An investigation was performed using qa retain strips from the same lot.The retain strips met all test specifications.The dhr was complete and contained all relevant data indicating the product put into finished goods met all specifications.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: 14147884
• MDR Text Key: 298914060
• Report Number: 1219029-2022-00026
• 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: 05/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• 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
• Date Manufacturer Received: 03/21/2022
• 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