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

Model Number	1.86
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer indicated that their statstrip wireless meter, serial number: (b)(4).Glucose result that was high compared to the readings reported from another meter.
Additional Manufacturer Narrative
Udi: (b)(4).The customer indicated that their statstrip wireless meter reported glucose result that was high compared to the readings reported from another meter.Dhr reviews for the statstrip glucose meter, sn (b)(6), and statstrip glucose test strips, lot 0321243249, were performed by the sr.Quality control manager.The reviews included an assessment of the production, testing, and release of the meters and test strip batch.No abnormalities or concerns were observed; the dhrs indicated that the released product met all specifications.The nova clinical applications department performed a mini correlation study which concluded that the statstrip glucose meter, sn (b)(6), has a good correlation to the laboratory reference method.The meter meets the recommended poct12-a3 clinical accuracy standard.Retain statstrip glucose test strips, lot 0321243249, met the performance acceptance criteria for linearity and whole blood specimens.All linearity results were within range and no discrepant results were observed for whole blood samples.No further action is required at this time, nova will continue to monitor for recurrence.

• Brand Name: STATSTRIP GLUCOSE HOSPITAL METER
• 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 8915
• Manufacturer Contact: shalomy mathew ; 200 prospect street; waltham, MA 02454-9141 ; 7816473700
• MDR Report Key: 13587682
• Report Number: 1219029-2022-00009
• Device Sequence Number: 4363733
• Product Code: PZI
• UDI-Device Identifier: 00385480547901
• UDI-Public: 00385480547901
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K150281
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2022

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 Model Number: 1.86
• Device Catalogue Number: 54802
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2022
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown