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

Catalog Number 6802584

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

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

Event Date 04/27/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that lower than expected, vitros glu and vitros crea results were obtained when processing a single non-vitros biorad l3 control fluid on a vitros 5600 integrated system.A definitive assignable cause could not be determined.The historical vitros glu and vitros crea quality control data show the reagents were not performing as expected in regards to precision.Therefore, reagent performance cannot be ruled out as a contributing factor.Diagnostic within-run precision testing to verify the instrument performance was requested but not provided.The instrument is reporting tx7-101 condition codes (ambient temperature is high) indicating an issue related to the temperature in the laboratory could be impacting instrument performance.Therefore, the instrument cannot be ruled out as a contributing factor.In addition, based on the unacceptable performance for multiple assays using the same quality control fluid, an issue related to the user's quality control fluid handling protocol cannot be ruled out as a contributing factor.

Event Description

A customer obtained lower than expected vitros glu and vitros crea results when processing a single non-vitros biorad l3 control fluid on a vitros 5600 integrated system.Biorad multiqual (lot45793) level 3 glu result 582, <20 mg/dl versus an expected result of 342.5 mg/dl.Biorad multiqual (lot45793) level 3 crea result 0.110 mg/dl versus an expected result of 6.83 mg/dl.A biased result of the direction and magnitude observed may lead to inappropriate medical action if not detected.The lower than expected, vitros glu and vitros crea results were obtained when processing quality control fluids and patient samples were not processed.However, the investigation could not conclude that patient results would not be affected if the event were to recur undetected.Ortho was not made aware of any patient harm.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).This report is number three of three mdr's for this event.Three 3500a forms are being submitted for this event as three devices were involved.

• Brand Name: VITROS CHEMISTRY PRODUCTS CREA SLIDES
• Type of Device: IN VITRO
• 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: 7542290
• MDR Text Key: 109642109
• Report Number: 1319809-2018-00085
• Device Sequence Number: 1
• Product Code: JFY
• 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: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2019
• Device Catalogue Number: 6802584
• Device Lot Number: 1515-3475-7061
• Other Device ID Number: 10758750002849
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2018
• 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