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 09/01/2021

Event Type  malfunction  

Event Description

The investigation determined that a lower and higher than expected vitros dgxn and phyt results were obtained from three different levels of non-vitros biorad control, lot 27750 using vitros dgxn slide lot 1924-0261-1419, vitros phyt slide lot 2621-0177-0738 and vitros phyt slide lot 2621-0177-0751 tested on two different vitros 5600 systems.(b)(6).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 three of three mdr¿s for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint (b)(4).

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 and vitros phyt slide lot 2621-0177-0751 tested on two different vitros 5600 systems.The most likely assignable cause of the event was determined to be user error due to multiple improper cartridge handling protocols.The customer indicated the vitros operators are leaving the vitros dgxn and phyt slide cartridges at room temperature for greater than 24 hours.The vitros dgxn and phyt instructions for use state to warm the wrapped cartridge at room temperature for 60 minutes and load the cartridges within 24 hours after they reach room temperature, 18¿28 °c (64¿82 °f).The customer will further discuss proper cartridge handling with the laboratory operators to mitigate the issue.Based on the historical quality control results, a performance issue with the vitros 5600 systems or the vitros dgxn and phyt slide lots in use cannot be ruled out as contributing to the event.However, it is unlikely that both vitros 5600 systems and two different slide lots of vitros phyt slides and one lot of dgxn would have performance issues within the timeframe of the event.In addition, a review of the worldwide complaint database for phyt lot 2621-0177-0738, phyt lot 2621-0177-0751, and dgxn lot 1924-0261-1419 complaints did not identify a quality issue with any of the slide lots.An issue with pre-analytical handling of the biorad qc fluid could not be ruled out as a potential contributor to the event.The investigation is ongoing and an ortho field engineer is expected onsite to further investigate.(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: 12780466
• MDR Text Key: 282222188
• Report Number: 1319809-2021-00162
• 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: 11/09/2021

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: 11/15/2021
• Device Catalogue Number: 8298671
• Device Lot Number: 2621-0177-0751
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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