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

Catalog Number 8433880

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a higher than expected vitros lac result was obtained from a single patient sample when two different sample collection devices were used for a single patient sample when tested on a vitros 5600 integrated system.The assignable cause of this event is user error, as the customer was using a sample collection device that is not recommended in the vitros lac instructions for use.There was no evidence to suggest a malfunction of the vitros lac reagent lot in use (lot 3531-0094-5661) or of the vitros 5600 integrated system.

Event Description

A customer obtained a discordant vitros lactate (lac) result on a vitros 5600 integrated system when two different collection devices were used for patient sample testing.Patient 2 sample vitros lac result 4.5 mmol/l versus expected 2.7 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if the event were to occur undetected.The discordant vitros lac result was not reported out of the laboratory and there was no allegation of actual patient harm as a result of this event.However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.This report corresponds to ortho clinical diagnostics (ortho) inc.Complaint numbers (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS LAC SLIDES
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: 6933696
• MDR Text Key: 90312062
• Report Number: 1319809-2017-00178
• Device Sequence Number: 1
• Product Code: KHP
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/01/2018
• Device Catalogue Number: 8433880
• Device Lot Number: 3531-0094-5661
• Other Device ID Number: 20758750004451
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2016
• 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