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

Catalog Number 44052

Device Problems Incorrect Measurement (1383); Low Test Results (2458); Erratic Results (4059)

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

Event Date 04/13/2021

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.

Event Description

The customer reported that a discrepant creatine result was reported when using a statsensor hospital meter and creatinine test strips , lot 4920279129.The patient was being prepped for a ct scan with contrast, however; the sample result of 1.6 was obtained on the meter and lab reported a result of 2.46 prior to the contrast being administered.There was no contrast given to the patient nor was there any patient harm or intervention noted.

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).This occurred on (b)(6) 2021.The meter did not indicate there was a problem with the sample or the result in anyway.The customer indicated the patient did not receive ct contrast for an upcoming ct scan because of the creatinine results from their lab analyzer.A concern was expressed that the meter produced a value too low when compared to the analyzer.No other treatments for the patient were affected.The meter was not returned to nova biomedical for investigation.As a result, retains of the test strip lot 4920279129 were used across fived different nova meters.All tests passed the acceptance criteria for linearity solutions and blood samples.No discrepancies were observed between blood results obtained by the retained test strips and the reference method, siemens exl analyzer, when used.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 the strips.A root cause was unable to be identified, and nova will continue to monitor for recurrence of similar events.

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.

• Brand Name: NOVA STATSENSOR CREATININE HOSPITAL METER
• Type of Device: CREATININE TEST SYSTEM
• Manufacturer (Section D): NOVA BIOMEDICAL CORP.; 200 prospect st; waltham MA 02454 9141
• MDR Report Key: 11813609
• MDR Text Key: 250257652
• Report Number: 1219029-2021-00019
• Device Sequence Number: 1
• Product Code: CGL
• Combination Product (y/n): N
• PMA/PMN Number: K070068
• 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: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 44052
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR