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 Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros phenytoin (phyt) results were obtained from a non-vitros biorad quality control (qc) fluid and from vitros therapeutic drug monitoring performance verifiers (tdm pv) using vitros chemistry products phyt slides lot 2619-0171-2892 on a vitros 5600 integrated system.The root cause of the event is an issue related to suboptimal calibrations.The cause of the suboptimal calibrations is unknown but could be related to improper maintenance protocol or another unknown issue with the calibrator kit.The customer was not following recommended maintenance procedures.The microslide incubator evaporation caps were found to be dirty, and the customer had not performed correction factors on the instrument in more than 6 months at the time of the event (every 6 months is recommended by ortho).After the customer performed recommended actions which included replacing the microslide incubator evaporation caps, performing the correction factors adjustment and performing the pad reflectance testing, they were able to obtain an optimal calibration and expected qc results.The customer had used a different lot of calibrators for the calibration event conducted after performing the maintenance procedures.Therefore, an unknown issue with the customers previous calibrator kit lot cannot be confirmed or ruled out as a potential cause of the higher than expected results.The investigation could not entirely rule out a malfunction of the vitros 5600 integrated system as vitros crbm precision testing passed while a vitros phyt within run precision test had failed.The customer did not perform a subsequent vitros phyt within run precision test after completing the recommended maintenance actions.An issue with the vitros phyt slides lot 2619-0171-2892 is not likely as results returned to expectations after an optimal calibration was generated.Furthermore, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros phyt lot 2619-0171-2892.

Event Description

A customer obtained higher than expected vitros phenytoin (phyt) results from a non-vitros biorad quality control (qc) fluid and from vitros therapeutic drug monitoring performance verifiers (tdm pv) using vitros chemistry products phyt slides on a vitros 5600 integrated system.Biorad lot 40980 l3 results of 30.13, 34.43, 29.80, 31.19, 28.09, 31.32, 31.93, 28.92, 30.42, 30.26, 29.63 and 29.04 ug/ml vs the expected result of 22.93 ug/ml.Vitros tdm pvii lot g6675 results of 18.59 and 18.32 ug/ml vs the expected result of 15.1 ug/ml.Vitros tdm pviii lot q7653 results of 39.63, 40.0 and 37.59 ug/ml vs the expected result of 28.6 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 qc fluids.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 is number 3 of 3 mdr¿s for this event.Three (3) 3500a forms are being submitted for this event as 3 devices were involved.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: 9734975
• MDR Text Key: 224392024
• Report Number: 1319808-2020-00013
• 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: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 8568040
• Device Lot Number: 0998
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2019
• 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