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 04/06/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected vitros glucose (glu) result was obtained from a vitros performance verifier (pv) processed using vitros chemistry products glu slides lot 0002-0973-4292 in combination with a vitros 350 chemistry system.The cause of the event is attributed to user error associated with the manual entry and use of calibration parameters from a previous glu slide lot.The customer had erroneously entered the calibration parameters from a previous lot of vitros glu reagent into the vitros 350 chemistry system for vitros glu lot 0002-0973-4292 instead of doing a wet calibration as per routine process.The vitros glu quality control results were acceptable after a new calibration event was performed using vitros glu reagent lot 0002-0973-4292 indicating vitros glu lot 0002-0973-4292 in combination with the vitros 350 system was returned to the expected performance.

Event Description

A customer reported a lower than expected vitros glucose (glu) result obtained from a vitros performance verifier (pv) processed using vitros chemistry products glu slides in combination with a vitros 350 chemistry system.Vitros pv ii lot j6978 vitros glu result of <20 mg/dl versus an expected result of 288.9 mg/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower than expected vitros glu result was from a quality control fluid.However, the investigation cannot conclude that patient samples would not be affected if the event were to recur undetected.There was no allegation 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: 10007142
• MDR Text Key: 218021755
• Report Number: 1319809-2020-00057
• 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: 04/28/2020

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: 05/01/2021
• Device Catalogue Number: 1707801
• Device Lot Number: 0002-0973-4292
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2019
• 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