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 10/23/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower and higher than expected vitros dgxn and phyt results were obtained from several levels of non-vitros biorad control, lot 27750 using vitros dgxn slide lot 1924-0261-1419, vitros phyt slide lot 2621-0177-0738, vitros phyt slide lot 2621-0178-3213 and vitros phyt slide lot 2621-0178-3878 tested on two different vitros 5600 systems.The investigation determined most likely assignable cause of the event to be user error due to improper sample or cartridge handling protocol issue at the site.Previously, the customer admitted that several vitros operators were using incorrect slide cartridge handling protocol.The vitros operators were leaving the vitros dgxn and phyt slide cartridges at room temperature for greater than 24 hours.The vitros dgxn and phyt instructions for use states the following: ¿warm the wrapped cartridge at room temperature for 60 minutes.¿ ¿load the cartridges within 24 hours after they reach room temperature, 18¿28 °c (64¿82 °f).¿ it has not been confirmed if a change in cartridge handling protocol has occurred.Based on acceptable within-run precision testing, an instrument related performance issue did not likely contribute to the event.In addition, as the precision passed when processing within run, it appears the issue is within lab (day to day, test event to test event).This would indicate an issue with fluid handling or slide cartridge handling.An ortho laboratory specialist will be requested to go on site to investigate any improper protocol issues.Since multiple lots of vitros dgxn and vitros phyt slide lots are affected, it is unlikely a reagent related performance contributed to the event.Continual tracking and trending did not detect a performance issue with any of the vitros dgxn or phyt slide lots in use at the site.Email address for contact office above is (b)(6).

Event Description

The investigation determined that lower and higher than expected vitros dgxn and dgxn results were obtained from non-vitros biorad control, lot 27750 using vitros dgxn slide lot 1924-0261-1419, vitros dgxn slide lots 2621-0177-0738, 2621-0178-3213, and 2621-0178-3878 tested on two different vitros 5600 integrated systems.Vitros 56002659 system: vitros dgxn slide lot 1924-0261-1419.Biorad l3 dgxn result of 1.99 ng/ml vs.An expected result of 2.94 ng/ml.Vitros dgxn slide lot 2621-0177-0738.Biorad l2 dgxn results of 4.47, 16.76, 17.06 and 16.23 ug/ml vs.An expected result of 13.49 ug/ml.Biorad l3 dgxn results of 10.54, 10.80, 12.05, 10.58, 34.90, 33.16, 33.67, 21.24, 17.25, 17.86, 10.72, 8.07, 9.14, 12.02, 15.14, 16.15, 21.06, 20.06, 14.69, 13.27, 18.82, 12.67, 20.91, 21.19, 14.53, 19.42, 5.14, 15.72, 15.99, 16.02, 16.42, 20.37, 4.04, 17.85, 16.20, 15.80 and 16.61 ug/ml vs.An expected result of 27.21 ug/ml.Vitros dgxn slide lot 2621-0178-3213.Biorad l3 dgxn results of 17.20, 21.26, 23.05, 23.82, 24.39, 15.44 and 17.61 ug/ml vs.An expected result of 35.0 ug/ml.Vitros dgxn slide lot 2621-0178-3878.Biorad l3 dgxn results of 19.68, 15.27, 21.46, 16.03, 16.39, 19.67, 16.29, 16.57, 16.37, 19.38, 18.82, 18.65 and 19.55 ug/ml vs.An expected result of 35.0 ug/ml.Vitros 56003892 system: vitros dgxn slide lot 1924-0261-1419 biorad l3 dgxn results of 1.67, 1.92, 1.99, 1.76, <0.40, 0.50, 1.88, 1.98, 0.50, 0.85 and 0.96 ng/ml vs.An expected result of 2.94 ng/ml.Vitros dgxn slide lot 2621-0177-0738.Biorad l2 dgxn results of 17.01, 16.56, 16.63, 10.29, 9.79, 16.68, 16.49, and 16.45ug/ml vs.An expected result of 13.49 ug/ml.Biorad l3 dgxn results of 15.42, 33.38, 33.26, 33.17, 14.13, 11.90, 14.71, 19.61, 10.90, 13.19, 10.78, 19.38, 4.39, 12.70, 6.90, 11.82, 9.83, 17.06, 7.77, 11.10, 18.89, 18.53, 16.78, 14.52, 14.50, 19.58, 18.76, 7.70, 33.44, 9.43, 9.91, 10.36, 9.76, 20.38, 16.49, 11.46, 16.03, 16.52, 15.21, 12.38, 18.92, 20.57, 21.37, 17.44, 4.88, 5.09, 20.33, 16.48, 21.65, 5.86, 13.81, and 15.60ug/ml vs.An expected result of 27.21 ug/ml.Vitros dgxn slide lot 2621-0177-3213 results.Biorad l3 dgxn results of 19.28, 21.82, 23.42, 22.91, 22.61, 22.02 and 18.42 ug/ml vs.An expected result of 35.0 ug/ml.Vitros dgxn slide lot 2621-0178-3878 results: biorad l2 dgxn results of 12.67 and 12.47 ug/ml vs.An expected result of 15.9 ug/ml.Biorad l3 dgxn results of 18.00, 22.64, 18.13, 18.46 and 17.14 ug/ml vs.An expected result of 35.0 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 affected quality control samples were non-patient quality control samples.The customer made no indication that patient sample results were affected.There were no reported allegations of patient harm.This report is number four of four mdr¿s for this event.Four 3500a forms are being submitted for this event as four devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (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
• 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: 12917023
• MDR Text Key: 289752535
• Report Number: 1319809-2021-00188
• 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: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Catalogue Number: 8298671
• Device Lot Number: 2621-0178-3878
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2021
• 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