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

Catalog Number 8150112

Device Problem High Test Results (2457)

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

Event Date 01/18/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros lac results were obtained from two different levels of non-vitros biorad multiqual unassayed control lot 47970, tested with vitros lac slide lot 3530-0103-5136 on a vitros 5600 integrated system.The investigation could not determine an assignable cause.The event suddenly occurred on (b)(6) 2019.Both acceptable and unacceptable vitros lac quality control results were obtained from two different affected cartridges, indicating the vitros lac slides in use did not likely contribute to the event.In addition, acceptable quality control results were obtained for 8 days prior to the event, using the same calibration event, indicating the event was not calibration driven.Acceptable quality control results were obtained after the event occurred, through the present, with no actions taken to improve performance.This indicates that vitros lac slide lot 3530-0103-5136 was performing as intended on the vitros 5600 integrated system since the event that occurred on (b)(6) 2019.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros lac slide lot 3530-0103-5136.

Event Description

A customer reported higher than expected quality control (qc) results obtained using vitros chemistry products lactate (lac) slides on a vitros 5600 integrated system.Non-vitros biorad quality control lot 47970.L1 vitros lac result of 2.10 mmol/l vs.The expected result of 1.43 mmol/l.L2 vitros lac results of 4.43, 4.44, and 4.41 mmol/l vs.The expected result of 3.49 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 unexpected vitros lac results were generated from non-patient fluids and the customer made no indication that patient samples were affected.There was no allegation of patient harm as a result of the event.This report is number 4 of 4 mdr¿s for this event.Four (4) 3500a forms are being submitted for this event as 4 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS LACTATE 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: 8387356
• MDR Text Key: 141342027
• Report Number: 1319809-2019-00012
• Device Sequence Number: 1
• Product Code: KHP
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2020
• Device Catalogue Number: 8150112
• Device Lot Number: 3530-0103-5136
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2018
• 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