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 06/23/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that reproducible, lower than expected vitros crea results were obtained from a single patient sample when processed on a vitros 5600 integrated system, when compared to the result obtained from a non-vitros roche method.The investigation was unable to determine a definitive assignable cause.However, since the issue was isolated to a single patient sample, an unknown sample interferent that affects the vitros assay, but not the non-vitros roche method, is the likely cause of the event, but this could not be confirmed.There was no indication the vitros 5600 integrated system malfunctioned, however, since no within-run precision performance testing was processed, an instrument related issue cannot be completely ruled out as contributing to the event.Additionally, the historical quality control data review indicates the vitros crea slides were performing as intended and did not likely contribute to the event.A definitive assignable cause for the event could not be determined.

Event Description

A customer obtained reproducible, lower than expected vitros creatinine (crea) results from a single patient sample tested on a vitros 5600 integrated system, when compared to the result obtained from a non-vitros roche method.Vitros crea results of 0.56 and 0.46 mg/dl vs.The expected result of 3.45 mg/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if the event were to occur undetected.The lower than expected crea results were not reported outside the laboratory and there were no reported allegations of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics (ortho) inc.Complaint numbers (b)(4) / qerts record id (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: 7716248
• MDR Text Key: 115673948
• Report Number: 1319809-2018-00100
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2019
• Device Catalogue Number: 6802584
• Device Lot Number: 1515-3474-6084
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2017
• 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