MAUDE Adverse Event Report: NOVA BIOMEDICAL CORP. NOVA STATSENSOR CREATININE HOSPITAL METER; CREATININE TEST SYSTEM

Model Number	44052
Medical Device Problem Codes	Incorrect Measurement (1383); Low Test Results (2458); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There is currently a pending investigation.Nova is requesting additional information, and further details will be provided in a supplemental report.This is report two of two.Please see report 1219029-2021-00021 for the first filing.
Event or Problem Description
Nova biomedical (nova) was made aware of a potential issue regarding discrepant creatinine results using a statsensor hospital meter, serial number (b)(4) and creatinine test strips lot 4920177139.It was reported the patient disagreed with the initial results.When samples were run on a lab analyzer, the results did not match those of the meter.No inappropriate treatment was started and the patient was not adversely affected by the result.This is report two of two.
Additional Manufacturer Narrative
Udi: (b)(4).The customer reported an incorrect patient result for creatinine was received when running a patient sample on a statsensor meter sn (b)(6).This occurred on april 13, 2021.The meter did not indicate there was a problem with the sample in anyway before producing the result.The customer indicated there was no adverse treatment of the patient due to the incident.The meter was returned to nova biomedical for investigation.The meter was tested with manufacturer retains of the strips with lot 4920177129.All tests passed the acceptance criteria for linearity solutions and blood samples when compared to five additional meters.No discrepancies were observed between blood results obtained by the retained test strips and the reference method, siemens exl analyzer, when used on the returned meter.Device history record (dhr) reviews were performed for the meter and the strip lot by a quality control engineer.The reviews included an assessment of the production, testing, and release of the meter and test strip batch.No abnormalities or concerns were noted, and the dhr indicated the released product met all specifications.The conclusion of the investigation is the reported customer complaint could not be confirmed after testing the returned meter and the manufacturer retains of the strips.A root cause was unable to be identified, and nova will continue to monitor for recurrence of similar events.Report 1 of 2.
Additional Manufacturer Narrative
An investigation has been initiated and is still pending.Further details will be provided in an additional supplemental report when they become available.
Additional Manufacturer Narrative
Please note, the previous report was dated for june 14th, 2021 (06/14/2021).This is an error.The correct date of the report is june 15th, 2021 (06/15/2021).Report 1 of 2.

• Brand Name: NOVA STATSENSOR CREATININE HOSPITAL METER
• Common Device Name: CREATININE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 9141
• MDR Report Key: 11812726
• Report Number: 1219029-2021-00022
• Device Sequence Number: 3792597
• Product Code: CGL
• UDI-Device Identifier: 00385480440523
• UDI-Public: 00385480440523
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K171059
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/15/2021

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 Model Number: 44052
• Device Catalogue Number: 44052
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 04/15/2021; 06/10/2021; 06/10/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 06/08/2021; 06/15/2021; 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1