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

Model Number	GLU TEST STRIP
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/28/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
There is currently a pending investigation.Nova is requesting additional information, and further details will be provided in a supplemental report.
Additional 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
• Common Device Name: 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
• Report Number: 1219029-2022-00026
• Device Sequence Number: 20282440
• Product Code: CGA
• UDI-Device Identifier: 10385480422144
• UDI-Public: 10385480422144
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K063821
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2022
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 04/19/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown