MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1; IN VITRO DIAGNOSTICS

Catalog Number 1882208

Device Problem High Test Results (2457)

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

Event Date 04/19/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that higher than expected lactate (lac) results were obtained from a vitros performance verifier (pv) quality control (qc) fluid using vitros chemistry products lac slides lot 3532-0110-6593 on a vitros 5600 integrated system.The assignable cause of the higher than expected vitros lac quality control results is most likely a suboptimal calibration.The slope value of the calibration from the day of the event of vitros lac reagent lot 3532-0110-6593 was abnormally high compared to the release value.After the reagent was recalibrated the parameters of that calibration were determined to be typical.The quality control results processed after the recalibration event were deemed acceptable.The cause of the suboptimal calibration is likely due to an issue related to the preparation of vitros cal kit 1 lot 0178.The customer suspected that a volumetric pipette was not used for the reconstitution process, however, this could not be confirmed as the customer was unable to verify which type of pipette was used.The instructions for use (ifu) for vitros cal kit 1 recommends using either a class a volumetric pipette or an automated pipette due to the sensitivity of the reconstitution process in maintaining the accuracy of the products.Recalibration with freshly prepped calibrator fluids resolved the issue.Historical qc results for vitros lac lot 3532-0110-6593 were not available as it was a new lot being put into use by the customer.After vitros lac lot 3532-0110-6593 was recalibrated, post calibration qc results were within expectations.Furthermore, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros lac reagent lot 3532-0110-6593.Although precision testing was not performed on the vitros 5600 integrated system an instrument related issue is not a likely contributor of the event as historical quality control results for the previous lot of vitros lac were precise.In addition, vitros lac reagent lot 3532-0110-6593 yielded acceptable qc results in combination with the vitros 5600 integrated system after a recalibration event without any troubleshooting actions being performed on the instrument.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report higher than expected lactate (lac) results obtained from vitros performance verifier (pv) quality control (qc) fluids using vitros chemistry products lac slides on a vitros 5600 integrated system.Vitros pv ii j6978 results of 5.09, 4.77, 4.78, 4.97, 4.84, 5.07 and 4.96 mmol/l vs.The expected result of 3.84 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros lac results were obtained from a quality control fluid and no results were reported from the laboratory.However, the investigation cannot conclude that patient samples would not be affected if the event were to recur undetected.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) / ivd 467825.

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
• 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: 10036491
• MDR Text Key: 232596502
• Report Number: 1319808-2020-00022
• 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: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2021
• Device Catalogue Number: 1882208
• Device Lot Number: 0178
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2019
• 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