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

Catalog Number 6802584

Device Problem Low Test Results (2458)

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

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected vitros creatinine (crea) result was obtained from a single patient sample tested on a vitros 5600 integrated system, when compared to the result from a non-vitros method.The investigation was unable to determine a definitive assignable cause.However, an unknown sample interferent that affects the vitros assay, but not the non-vitros method, is the likely cause of the event, but this could not be confirmed.The historical quality control data review indicates the vitros crea slides were performing as intended on the vitros 5600 system, therefore, it is not likely a reagent or instrument issue contributed to the event.Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros crea slide lot 1515-3481-0816.A definitive assignable cause for the event could not be determined.

Event Description

A customer obtained a lower than expected vitros creatinine (crea) result from a single patient sample tested on a vitros 5600 integrated system, when compared to the result from a non-vitros method.Patient sample crea result of 40.5 umol/l vs.The expected result of 192.7 umol/l biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.It was unknown whether the lower than expected vitros crea result was reported outside the laboratory.However, there was no allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CREA SLIDES
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: 8170744
• MDR Text Key: 131796196
• Report Number: 1319809-2018-00165
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: LH
• 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: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2019
• Device Catalogue Number: 6802584
• Device Lot Number: 1515-3481-0816
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2018
• 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