MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS LAC SLIDES; IN VITRO DIAGNOSTICS

Catalog Number 8150112

Device Problem High Readings (2459)

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

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that higher than expected lactate results were obtained from a vitros performance verifier (pv) quality control (qc) fluid using vitros chemistry products lac slides lot 3532-0108-3860 on a vitros 350 chemistry system.A definitive assignable cause could not be determined.Based on historical quality control results, a vitros lac reagent lot 3532-0108-3860 performance issue is not a likely contributor to the event.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 3532-0108-3860.However, the customer exhausted their supply of vitros lac lot 3532-0108-3860 and no additional troubleshooting using this lot was able to be performed.The issue was resolved when using an alternate lot of vitros lac reagent.Therefore, an issue related to vitros lac lot 3532-0108-3860 could not be completely ruled out nor confirmed as a contributing factor of the event.Although precision testing was not performed on the vitros 350 chemistry system an instrument related issue is not a likely contributor of the event as historical quality control results were precise and an alternate lot of vitros lac reagent yielded acceptable results in combination with the vitros 350 chemistry system without any troubleshooting actions being performed on the instrument.Because fresh vials of the vitros pv i and pv ii control fluids were used as part of troubleshooting by the customer, an issue related to the vitros pv fluids cannot be ruled out nor confirmed as a contributor of the event.

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 350 chemistry system.Vitros pv ii l7425 results of 4.8 and 4.9 mmol/l vs.The expected result of 3.9 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 is number 2 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.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS LAC SLIDES
• 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; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 9889722
• MDR Text Key: 227201816
• Report Number: 1319809-2020-00041
• Device Sequence Number: 1
• Product Code: KHP
• 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: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: 8150112
• Device Lot Number: 3532-0108-3860
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2019
• 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