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

Catalog Number 1707801

Device Problem Low Test Results (2458)

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

Event Date 01/20/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected vitros glucose (glu) result was obtained from a patient sample processed using vitros chemistry products glu slides on a vitros 5600 integrated system.An assignable cause of this event could not be determined.Based on historical quality control results a vitros glu slides lot 0047-0957-4800 performance issue is not a likely contributor to the event.Furthermore, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros glu reagent lot 0047-0957-4800.Additionally, an instrument issue did not likely contribute to the event.Precision testing performed by the customer yielded results that were within acceptable guidelines indicating that the instrument was operating as intended.

Event Description

A customer reported a lower than expected vitros glucose (glu) result from a single patient sample processed using vitros chemistry products glu slides in combination with a vitros 5600 integrated system.Vitros glu result of 40 mg/dl versus an expected result of 530 mg/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected vitros glu result was reported to the physician.However, no treatment was initiated or changed based on the reported result as the physician had questioned the result, and instead treated based on glucometer results.A corrected report was later issued after the sample was retested and there were no allegations of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS GLU 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: 8339987
• MDR Text Key: 139091398
• Report Number: 1319809-2019-00007
• Device Sequence Number: 1
• Product Code: CGA
• 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: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• 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: 1707801
• Device Lot Number: 0047-0957-4800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2018
• 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