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

Catalog Number 6802584

Device Problem High Test Results (2457)

Patient Problem Insufficient Information (4580)

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

Email address for contact office is (b)(4).The investigation has determined that higher than expected vitros creatinine results were obtained from a single patient sample using vitros chemistry products crea slides lot 1523-3498-5555 on a vitros xt7600 integrated system.The assignable cause of the event is unknown.Historical qc was acceptable, indicating that the vitros crea reagent in combination with the vitros xt7600 integrated system was performing as expected.The pressure profiles from the two metering events each day the samples were tested were reviewed, and it was confirmed that the sample viscosity is similar between the two events and the fluid height decreased between the first and second metering events.This suggests testing was performed from the same sample collection container, and that a sample mix-up is not likely.Within run precision testing performed using vitros performance verifier fluids was within ortho acceptable guidelines, indicating that the analyzer in combination with the reagent was performing as expected at the time the precision was run.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 samples, although this could not be confirmed.

Event Description

A customer contacted an ortho clinical diagnostics (ortho) laboratory specialist (ls) to report non-reproducible, higher than expected creatinine results obtained from a single patient sample processed using vitros chemistry products crea slides on a vitros xt7600 integrated system.Patient sample results of 234.7 and 236.3 umol/l vs.The expected result of 92.9 umol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros crea result was reported from the laboratory.It is unknown if a corrected report was issued.No treatment was altered based on the results.There was no allegation of patient harm as a result of this event.This report is number 1 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.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: joseph falvo ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10871092
• MDR Text Key: 249655598
• Report Number: 1319809-2020-00137
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: RP
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: 6802584
• Device Lot Number: 1523-3498-5555
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2019
• 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