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

Model Number	45335
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
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 one of two.Please see report 1219029-2021-00025 for the second filing.
Event or Problem Description
Customer reported discrepant patient results.A test was run on the statsensor meter serial number (b)(4) with test strip lot 4920227129, and the creatinine was reading overly high with an overly low egfr.There was no patient harm or medical intervention.
Additional Manufacturer Narrative
Product was received for evaluation on 07-19-21.An investigation has been initiated and is currently pending.Further details will be provided in an additional supplemental report when they become available.
Additional Manufacturer Narrative
Udi: (b)(4).The customer reported an incorrect result was received for creatinine while running a patient sample on a statsensor meter, serial number (b)(6) with test strip lot 4920227129.This event occurred on may 10, 2021.The customer stated the meter had passed the quality control requirements for creatinine.The meter was returned to nova biomedical for investigation.The testing strips used by the customer were not returned to the manufacturer.Manufacturer retains of strip lot 4920227129 were unavailable for testing.As a result, strip lot 4920279129, the oldest available lot, was used for the investigation in place of the customer strips.These strips were tested across five nova biomedical meters along with the returned customer meter.All tests passed the acceptance criteria for linearity solutions and blood samples.No discrepancies were observed between blood results obtained by the returned meter, the manufacturer meters, and the reference analyzer when compared.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 manufacturer retains of strip lot 4920279129, the oldest lot available, and the returned customer meter.A root cause which lead to the initial complaint could not be identified, and nova biomedical will continue to monitor for recurrence of similar events.

• Brand Name: NOVA STATSENSOR CRETININE HOSPITAL METER SYSTEM
• Common Device Name: CREATININE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 9141
• MDR Report Key: 12041568
• Report Number: 1219029-2021-00024
• Device Sequence Number: 3235681
• Product Code: CGL
• UDI-Device Identifier: 00385480453356
• UDI-Public: 00385480453356
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 08/18/2021

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: 45335
• Device Catalogue Number: 45335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2021
• Supplement Date Received by Manufacturer: 07/19/2021; 08/18/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 07/20/2021; 08/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR