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

Catalog Number 8892382

Device Problem High Test Results (2457)

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

Event Date 11/06/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that a non-reproducible, higher than expected vitros crbm result was obtained from a single patient sample using vitros chemistry products crbm slides lot 3946-0106-2435 on a vitros 5,1 fs chemistry system.A definitive assignable cause of the non-reproducible, higher than expected result could not be determined.Based on historical quality control results and quality control results on the day of the event, a vitros crbm reagent performance issue is not a likely contributor to the event.Furthermore, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros crbm reagent lot 3946-0106-2435.Vitros crbm marker precision testing performed by the customer on the vitros 5,1 fs chemistry system was within ortho acceptable guidelines suggesting an instrument issue was not likely a contributing factor.Additionally, pre-analytical sample processing could not be ruled out as a contributing factor as it is unknown if the customer was following the sample collection device manufacturer¿s recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report a non-reproducible, higher than expected carbamazepine (crbm) result obtained from a single patient sample using vitros chemistry products crbm slides on a vitros 5,1 fs chemistry system.Patient sample result of 15.1 ug/ml vs.The expected result of 8.7 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 non-reproducible, higher than expected vitros crbm result was not reported from the laboratory.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CRBM 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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 9401355
• MDR Text Key: 214624010
• Report Number: 1319809-2019-00117
• 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: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/01/2020
• Device Catalogue Number: 8892382
• Device Lot Number: 3946-0106-2435
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2019
• 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