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

Catalog Number 8892382

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros carbamazepine (crbm) results were obtained from a single non-vitros (biorad) control tested on a vitros 5600 integrated system.The assignable cause of the event is unknown, but is not likely a calibration driven event.The higher than expected results were generated from a calibration event that occurred on (b)(6) 2018, however, the event did not occur until (b)(6) 2018.Acceptable results were obtained for the timeframe of (b)(6) 2018.A fluid or vitros crbm slide related issue is unlikely as acceptable results were obtained on an alternate vitros 5600 system on site using the same lot of vitros crbm slides and biorad controls.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issues with vitros product crbm slides, lot 3943-0103-2834.An instrument related issue did not likely contribute to the event as a vitros crbm within-run precision test, used to assess the performance of the vitros immunorate subsystem of the vitros 5600 system, generated acceptable results.

Event Description

A customer obtained higher than expected vitros carbamazepine (crbm) results from a single non-vitros (biorad) control tested on a vitros 5600 integrated system.Biorad level 3 (l3) crbm result of 18.3 and >20.0 ug/ml vs.The expected result of 11.1 ug/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The higher than expected vitros crbm results were generated from a non-patient fluid, however the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There was no allegation of actual patient harm as a result of this event.This report is number 2 of 2 mdrs for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CRBM SLIDES
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 8229104
• MDR Text Key: 133841355
• Report Number: 1319809-2019-00002
• Device Sequence Number: 1
• Product Code: KLT
• 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: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Catalogue Number: 8892382
• Device Lot Number: 3943-0103-2834
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1