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

Model Number 45335

Device Problem Erratic Results (4059)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2021

Event Type  malfunction  

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.

Event 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 egfr was running low for the patient.There was no patient harm or medical intervention.

Manufacturer Narrative

Additional information: b4, d9, g3, g6, h2, h10.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.

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 19, 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
• Type of Device: CREATININE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 9141
• MDR Report Key: 12041582
• MDR Text Key: 257458169
• Report Number: 1219029-2021-00025
• Device Sequence Number: 1
• Product Code: CGL
• UDI-Device Identifier: 00385480453356
• UDI-Public: 00385480453356
• Combination Product (y/n): N
• PMA/PMN Number: K171059
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1