MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS PHYT SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number 8298671

Device Problem Low Test Results (2458)

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

Event Date 10/05/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected vitros phyt quality control result was obtained from a vitros tdm pv3 qc fluid when using vitros chemistry products phyt slide lot 2621-0177-1319 on a vitros xt 7600 integrated system.The cause of this event was a combination of pre-analytical fluid handling of the immunowash fluid and vitros tdm pv fluids.The issue occurred following calibration of a new vitros phyt lot.The customer used an iwf fluid reservoir that was onboard for at least 2 days (stability is 3 days) for the phyt calibration event.When a fresh iwf reservoir was loaded the next day, the tdm qc result was lower than expected.In addition, the customer was not consistently warming the vitros tdm pv controls to room temperature prior to testing as ortho recommends.Recalibration with fresh reagents in combination with proper fluid warmup has resolved the issue.A successful within run diagnostic precision test concludes the vitros xt 7600 system was performing as expected and an instrument issue has been ruled out as a contributor to the event.A review of complaints from the worldwide complaint database did not identify a systemic issue with vitros chemistry products phyt lot 2621-0177-1319.Additionally, continual tracking and trending of complaints has not identified any signals that would point to a potential issue with vitros phyt lot 2621-0177-1319.(b)(4).

Event Description

The investigation determined that a lower than expected vitros phyt quality control result was obtained from a vitros tdm performance verifier 3 (tdm pv3) quality control (qc) fluid when using vitros chemistry products phyt slide lot 2621-0177-1319 on a vitros xt 7600 integrated system.Tdm pv3 d8377 = 20.4 ug/ml versus expected 26.3 ug/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The customer made no allegation that patient results were affected or reported from the laboratory.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS PHYT SLIDES
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• MDR Report Key: 12744060
• MDR Text Key: 283786374
• Report Number: 1319809-2021-00158
• Device Sequence Number: 1
• Product Code: DIP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 11/03/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2021
• Device Catalogue Number: 8298671
• Device Lot Number: 2621-0177-1319
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/06/2021
• Initial Date FDA Received: 11/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1