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

Catalog Number 8568040

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 09/17/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that both higher and lower than expected vitros phenytoin (phyt) results and higher than expected vitros carbamazepine (crbm) results were obtained on quality control fluids when tested using vitros chemistry products phyt slides and vitros chemistry products crbm slides in combination with a vitros 4600 chemistry system.The root cause was likely compromised sets of vitros chemistry products calibrator kit 9.Cloudiness in the calibrator vials was indicated, however, the exact cause of the cloudiness is unknown.The product is not available for further evaluation.Precision testing indicated the system was performing acceptably.Additionally, the slides and control fluids performed acceptably after a calibration was performed using non-compromised calibrators.A review of complaints specific to contamination for kit 9 did not identify any other complaints for cloudiness or particulates in the calibrator vials.Continual tracking and trending of complaints has not shown any existing signals that would point to a potential systemic issue with vitros chemistry products calibrator kit 9 lot 957.

Event Description

A customer obtained both higher and lower than expected results on multiple quality control (qc) fluid samples after calibrating vitros chemistry products phenytoin (phyt) slides using a vitros 4600 chemistry system.The customer also reported higher than expected qc results after calibrating vitros chemistry products carbamazepine (crbm) slides using a vitros 4600 chemistry system.Vitros chemistry products phyt slides, lot 2617-0167-1487: control fluid results of 12.3, 12.5, 11.6, 12.2, 12.4, 12.2, 13.0, 11.7, 10.5, 11.1 and 11.1 ug/ml were obtained with an expected serum result of 7.6 ug/ml.Control fluid results of 30.4, 32.9, 24.8, 31.4, 30.7, 31.1, 33.4, 28.9, 23.6, 25.6, 22.7 and 11.9 ug/ml were obtained with an expected serum result of 15.1 ug/ml.Control fluid results of 40.0, 39.8, 36.7, 33.6, 40.0, 40.0 and 38.2 ug/ml were obtained with an expected serum result of 24.3 ug/ml.Vitros chemistry products crbm slides, lot 3939-0100-5621.Control fluid results of 17.1, 17.2, 17.3, 17.5, 17.2, 17.4, 16.9, 16.8, 17.0, 17.1, 17.7, 18.2 and 17.4 ug/ml were obtained with an expected serum result of 12.89 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 vitros phyt and crbm results were generated from non-patient fluids and no results were reported outside the lab.There was no allegation of patient harm as a result of this event.This report is number 1 of 2 mdr¿s 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.Complaint numbers (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: 8024044
• MDR Text Key: 127254886
• Report Number: 1319808-2018-00043
• Device Sequence Number: 1
• Product Code: JIT
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2019
• Device Catalogue Number: 8568040
• Device Lot Number: 957
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2017
• 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