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 05/25/2022

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros phenytoin (phyt) quality control results were obtained from a non-vitros biorad qc fluid when using vitros chemistry products phyt slide lot 2621-0180-7298 on a vitros 5600 integrated system.Biorad level 2 lot 85262 result of 39.5 umol/l versus the expected baseline mean of 50.6 umol/l.Biorad level 3 lot 85263 result of 61.9 umol/l versus the expected baseline mean of 84.0 umol/l.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 is number one of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

Manufacturer Narrative

The investigation determined that lower than expected vitros phenytoin (phyt) quality control results were obtained from a non-vitros biorad qc fluid when using vitros chemistry products phyt slide lot 2621-0180-7298 on a vitros 5600 integrated system.The assignable cause of the event cannot be determined with the information provided.Historical quality control results were not as expected at higher vitros phyt concentrations, indicating that a reagent issue cannot be ruled out as a contributor to the event.However, continual tracking and trending does not indicate a quality issue related to vitros phyt slide lot 2621-0180-7298.A transient instrument issue that occurred on the day of the event, (b)(6) 2022, cannot be ruled out as a contributor.The customer obtained condition codes on this date that included ¿tj8-7be: wf metering hysteresis test failure - pressure did not return¿ and ¿tj6-41j: wf metering no protuberance during dispense sched56¿ when running another assay that uses the immunowash fluid (iwf) and the associated metering system.The customer additionally obtained lower than expected results when running vitros phyt proficiency fluids on (b)(6) 2022.On (b)(6) 2022, the day the customer contacted the tsc, it was indicated that the iwf tubing and microtip had been replaced a few months ago and resolved the errors.It was suspected that this occurred on the day of the event, although this could not be confirmed by the customer.A successful within run vitros phyt precision test performed on (b)(6) 2022 concludes the in-use lot of vitros phyt in combination with the vitros 5600 system is currently performing as expected.Email address for contact office in field above is (b)(6).

• 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
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 15285903
• MDR Text Key: 305429663
• Report Number: 1319809-2022-00061
• Device Sequence Number: 1
• Product Code: DIP
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Catalogue Number: 8298671
• Device Lot Number: 2621-0180-7298
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1