MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CRBM SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number 8892382

Device Problem High Test Results (2457)

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

Event Date 09/26/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros carbamazepine (crbm) results were obtained from a single level of non-vitros biorad immunoassay plus control lot 85310 tested on a xt7600 integrated system.The assignable cause of the event could not be determined.Pre-analytical sample mix-up between the biorad level 2 and level 3 control fluids is a potential cause of the event as the higher than expected biorad level 2 results are similar to the results obtained from the biorad level 3 control fluid.The customer could verify if pre-analytical sample mixup occurred, therefore, an issue with the vitros crbm slides in use at the time of the event could not be ruled out as the assignable cause.Vitros crbm results obtained from vitros therapeutic drug monitoring performance verifier fluids within the timeframe of the event were within established ranges, indicating acceptable accuracy after the event.However, no vitros tdm pv fluids were tested within the timeframe of the event, and it is unknown if vitros crbm lot 3913-0122-3158 was performing as intended when the event occurred.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros product crbm slides, lot 3913-0122-3158.The customer made no indication the vitros xt7600 system was not performing as intended, however, since no diagnostic within-run precision test was performed to assess instrument performance, an instrument related performance issue cannot be completely ruled out as contributing to the event.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros carbamazepine (crbm) results were obtained from a single level of non-vitros biorad immunoassay plus control lot 85310 tested on a xt7600 integrated system.Biorad lot 85310 level 2 crbm results of 9.69, 9.24 and 9.79 ug/ml vs.The expected result of 6.22 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 higher than expected vitros crbm results were obtained from non-patient quality control fluids.There was no reported allegations of patient harm as a result of this event.This report is number two 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 number (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CRBM SLIDES
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18059250
• MDR Text Key: 327267452
• Report Number: 0001319809-2023-00130
• Device Sequence Number: 1
• Product Code: KLT
• UDI-Device Identifier: 10758750005185
• UDI-Public: 10758750005185
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2024
• Device Catalogue Number: 8892382
• Device Lot Number: 3913-0122-3158
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1