MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2; IN VITRO DIAGNOSTICS

Catalog Number 1662659

Device Problem High Test Results (2457)

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

Event Date 08/31/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that a higher than expected result was obtained from a vitros performance verifier (pv) quality control (qc) fluid using vitros chemistry products k+ slides on a vitros 350 chemistry system.The assignable cause of the higher than expected vitros k+ quality control result is most likely a suboptimal calibration.The slope and intercept values of the initial calibration of vitros k+ reagent lot 4102-1016-9431 were abnormally high compared to the release values.After the reagent was calibrated a second time on the same day, the slope and intercept values of the recalibration were comparable to the release values.The quality control results, and a patient sample result tested after the second calibration event were deemed acceptable.The cause of the suboptimal calibration is unknown.Based on historical quality control results as well as qc results after the second calibration event on (b)(6) 2019, a vitros k+ reagent lot performance issue is not a likely contributor to the event.In addition, a vitros cl- calibration was determined to be suboptimal at the time of the atypical vitros k+ calibration.After both assays were calibrated a second time, optimal calibrations were obtained for each assay.Furthermore, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros k+ reagent lot 4102-1016-9431.Within run precision testing was not performed on the vitros 350 chemistry system.However, there was no evidence to suggest that the vitros 350 chemistry system was a contributing factor of the event.The higher than expected result was obtained from a quality control fluid and no results were reported from the laboratory.No patient sample results were reported from the laboratory.Ortho has not been made aware of any allegation of patient harm as a result of this event.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report higher than expected results obtained from a vitros performance verifier (pv) quality control (qc) fluid using vitros chemistry products k+ slides and vitros chemistry products cl- slides on a vitros 350 chemistry system.Vitros pv i lot f6662 k+ result of 3.6 mmol/l vs an expected result of 2.9 mmol/l.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 obtained from a quality control fluid and no results were 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 number (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
• 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: 9084485
• MDR Text Key: 220568272
• Report Number: 1319808-2019-00032
• Device Sequence Number: 1
• Product Code: JIX
• 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: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2020
• Device Catalogue Number: 1662659
• Device Lot Number: 0298
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2018
• 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