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 No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros crea results were obtained from a single patient sample processed using vitros chemistry products creatinine (crea) slides in combination with two different vitros 5600 integrated systems.The results were compared to the result of a second sample collected from the same patient.The most likely assignable cause of the event is a sample related issue due to an unknown sample interferent.It is possible that sample 1 contained an unknown sample interferent or that a contaminant was inadvertently introduced during the collection of the sample.In addition, a pre-analytical sample mix up could not be completely ruled out as a contributor to the event.The performance of the vitros 5600 integrated system was assessed with precision testing which yielded results that were within acceptable guidelines indicating that the analyzer was performing as intended.Based on historical quality control results a vitros crea lot 1515-3481-0363 performance issue is not a likely contributor to the event.Furthermore, continual analysis of complaints has not identified any signals that would suggest there is a systemic issue with vitros crea reagent lot 1515-3481-0363.

Event Description

A customer reported higher than expected vitros crea results from a single patient sample processed using vitros chemistry products creatinine (crea) slides in combination with two different vitros 5600 integrated systems.Patient sample 1 crea results of 5.2, 3.6, 3.6, 3.7 and 3.5 mg/dl vs.The expected result of 1.4 mg/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The initial higher than expected vitros crea result of 5.2 mg/dl was reported from the laboratory, however, the result was questioned and no treatment was initiated, altered, or withheld based on the reported result.There were 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: 8139068
• MDR Text Key: 130621914
• Report Number: 1319809-2018-00147
• 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: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• 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: 1515-3481-0363
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2018
• 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