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

Catalog Number 1632660

Device Problem High Test Results (2457)

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

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined the higher than expected vitros li results were obtained for multiple samples from a single patient processed on a vitros 5600 integrated system.The assignable cause of the event was user error associated with processing lithium testing on the vitros analyzer using a sample tube type (lithium heparin) that is not recommended for use with the vitros lithium assay per the vitros lithium instructions for use.

Event Description

The customer obtained higher than expected vitros lithium (li) results for multiple samples drawn from a single patient processed using a vitros 5600 integrated system.Patient sample results of 1.4 and 1.7 mmol/l vs.The expected result of 0.3 mmol/l biased results of the direction and magnitude observed may lead to inappropriate physician action.The lithium results were reported out of the laboratory and questioned by an emergency room medical professional.It was confirmed that no treatment was altered, initiated or stopped based upon the reported results.It was expected that a corrected report with only the serum lithium result would be sent out.There was no allegation of patient harm as a result of this event.This report is number 1 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS LI 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: 7440812
• MDR Text Key: 106604459
• Report Number: 1319809-2018-00067
• Device Sequence Number: 1
• Product Code: JIH
• 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: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Catalogue Number: 1632660
• Device Lot Number: 3126-0111-5481
• Other Device ID Number: 10758750009466
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2018
• Initial Date FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2017
• 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