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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that a non-reproducible, lower than expected creatinine result was obtained from a single patient sample processed using vitros chemistry products crea slides lot 1523-3494-1976 on a vitros xt7600 integrated system.A definitive assignable cause could not be determined.However, the most likely cause of the event is a sample related issue.After the initial sample was processed, results for two different vitros assays including vitros crea, were lower than expected.Following a redraw of the patient, the results obtained using both vitros assays were within expectations.Pre-analytical sample processing could not be ruled out as a contributing factor of the event.It is unknown if the customer was following the sample collection device manufacturer¿s recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Based on historical quality control (qc) results, a vitros crea reagent lot 1523-3494-1976 performance issue could not be ruled out as a contributor to the event.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros crea reagent lot 1523-3494-1976.An issue with the vitros xt7600 integrated system could not be entirely ruled out as a contributor to the event as historical qc results were imprecise compared to peer data and no precision testing was performed on the instrument.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report a non-reproducible, lower than expected creatinine result obtained from a single patient sample processed using vitros chemistry products crea slides on a vitros xt7600 integrated system.Patient 1 sample result of 0.34 mg/dl vs.The expected result of 2.25 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 crea result was reported from the laboratory.A physician questioned the result and corrected reports were later issued.No treatment was initiated, altered or stopped based on the lower than expected result and there have been no allegations of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (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: 10599454
• MDR Text Key: 231139188
• Report Number: 1319809-2020-00111
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: 6802584
• Device Lot Number: 1523-3494-1976
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2019
• 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