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

Catalog Number 8298671

Device Problem Low Test Results (2458)

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

Event Date 04/21/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected vitros phyt result was obtained from a single patient sample on a vitros 4600 chemistry system.The investigation was unable to determine a definitive assignable cause.Based on historical phyt quality control performance, a reagent issue is not a likely contributing factor to this event.A vitros 4600 chemistry system issue could not be ruled out as the customer declined precision testing to confirm instrument performance.In addition, improper pre-analytical sample processing could not be ruled out as a contributing factor as the customer was not adhering to the sample collection device manufacturer¿s recommendations for sample centrifugation.The assignable cause is unknown.

Event Description

A customer obtained a lower than expected vitros phyt result from a single patient sample, using vitros phyt slides on a vitros 4600 chemistry system.Patient result = 8.2 ug/ml versus an expected result of 26.0 ug/ml.Biased results of the direction and magnitude observed could lead to inappropriate physician action.The lower than expected vitros phyt patient result was reported outside of the laboratory, however, the result was questioned by the physician and a repeat test was performed.A corrected report was subsequently issued and there was no allegation of actual patient harm as a result of this event.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS PHYT 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: 5669201
• MDR Text Key: 46680019
• Report Number: 1319809-2016-00070
• Device Sequence Number: 1
• Product Code: DIP
• 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: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2016
• Device Catalogue Number: 8298671
• Device Lot Number: 2614-0158-8776
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1