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

Catalog Number 6802584

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/30/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a non-reproducible, lower than expected vitros crea result was obtained from a single patient sample processed using vitros chemistry products creatinine (crea) slides lot 1523-3494-2980 in combination with a vitros 5600 integrated system.Historical quality control results indicate vitros crea lot 1523-3494-2980 in combination with the vitros 5600 system is performing as expected in regard to both accuracy and within laboratory precision.In addition, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros crea slides lot 1523-3494-2980.The viscosity obtained when initially processing the patient sample differed from the viscosity when the sample was reprocessed on the same vitros 5600 system and a vitros 5,1 fs system.In addition, a vitros na+ result obtained when the sample was initially tested differed from the na+ results obtained when the same sample was reprocessed on the vitros 5600 system and the 5,1 fs system.Therefore, the potential cause of the non-reproducible, lower than expected vitros crea result is an issue related to pre-analytical sample handling.

Event Description

A customer reported a non-reproducible, lower than expected vitros crea result obtained from a single patient sample processed using vitros chemistry products creatinine (crea) slides in combination with a vitros 5600 integrated system.Patient sample vitros crea result 1.1 mg/dl versus repeat vitros crea results 5.9, 5.8 and 5.7 mg/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The non-reproducible, lower than expected vitros crea result was reported to the physician; however, ortho was not made aware of any allegation of patient harm.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CREA 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: 10201721
• MDR Text Key: 241410327
• Report Number: 1319809-2020-00067
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: 6802584
• Device Lot Number: 1523-3494-2980
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2019
• 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