MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9; IN VITRO DIAGNOSTICS

Catalog Number 8568040

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that multiple higher than expected vitros phenytoin (phyt) results were obtained on a quality control (qc) fluid when tested using vitros chemistry products phyt slides in combination with a vitros 4600 chemistry system.The most likely assignable cause of the higher than expected vitros phyt results is a suboptimal calibration.Historical quality control results obtained prior to a calibration event on 29 march 2019 indicated acceptable performance of vitros phyt lot 2618-0169-6410 in combination with the vitros 4600 chemistry system.Acceptable performance was resumed after an additional calibration was performed on 01 april 2019.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros phyt lot 2618-0169-6410.In addition, review of the calibration parameters obtained from the initial 04 march 2019 calibration of vitros phyt lot 2618-0169-6410 were typical to the database, while the calibration parameters obtained from the calibration event on 29 march 2019 were atypical.The acceptable quality control results obtained after the initial calibration on 04 march 2019 verify the accuracy of the calibration event.The unacceptable higher than expected quality control results obtained after the calibration event on 29 march 2019 indicate the calibration did not produce accurate vitros phyt results.Acceptable qc performance was restored after the calibration event that took place on 01 april 2019.An instrument issue is not a likely contributor of the event.Within run vitros phyt precision testing conducted on the vitros 4600 chemistry system produced higher than expected results using the calibration from 29 march 2019.However, the same testing performed using the calibration from 01 april 2019 yielded results that were within acceptable guidelines.

Event Description

A customer obtained higher than expected vitros phenytoin (phyt) results from a vitros therapeutic drug monitoring performance verifier (tdm pv) quality control (qc) fluid using vitros chemistry products phenytoin slides on a vitros 4600 chemistry system.Vitros tdm pviii lot b6280: vitros phyt results 33.26, 36.76, >40, >40, 39.98, 39.85, 36.25, 37.69, 38.76, >40, >40, >40, 39.41, 39.56, >40, >40, >40, >40, >40 and >40 ug/ml versus an expected vitros phyt result of 27.19 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 results were attained from a qc fluid.However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There have not been any allegations of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 9
• 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; 1000 lee road; rochester NY 14606
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 8551886
• MDR Text Key: 203128174
• Report Number: 1319808-2019-00013
• Device Sequence Number: 1
• Product Code: JIT
• 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: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2020
• Device Catalogue Number: 8568040
• Device Lot Number: 988
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2018
• 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