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

Catalog Number 8298671

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 06/22/2022

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical service center (tsc) to report non-reproducible, higher and lower quality control results were obtained using non-vitros biorad quality control fluid with the current, in-use vitros phyt slide lot on a vitros xt7600 integrated system.Vitros biorad l3 results of 33.9, 32.7, 26.8, 26.5, 15.8, 16.1, 16.5, 16.4, 14.9, 25.9, 15.2, 16.7 and 16.8 ug/ml vs.The expected result of 26.26 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.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number thirteen of thirteen mdr¿s for this event.Thirteen 3500a forms are being submitted for this event as thirteen devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number: (b)(4).

Manufacturer Narrative

The investigation determined that higher and lower than expected vitros phyt quality control results were obtained from a single level of non-vitros biorad lot: 85260 controls using vitros phyt slide lot: 2621-0180-9363 on a vitros xt7600 integrated system.The definitive cause of the event could not be determined with the information provided.Historic quality control results using vitros phyt slide lot: 2621-0180-9363 was not acceptable for within-lab precision.In addition, diagnostic within-run precision testing using vitros phyt slide lot: 2621-0180-9363 was not performed on the vitros xt7600 integrated system, therefore, a vitros xt7600 system or vitros phyt slide lot: 2621-0180-9363 performance issue cannot be ruled out as contributing to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros phyt slide lot: 2621-0180-9363.Email address for contact office in mfr site 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: 15194867
• MDR Text Key: 304970200
• Report Number: 1319809-2022-00059
• Device Sequence Number: 1
• Product Code: DIP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2022
• Device Catalogue Number: 8298671
• Device Lot Number: 2621-0180-9363
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2022
• 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