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

Catalog Number 8298671

Device Problem Low Test Results (2458)

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

Event Date 04/27/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros phyt results were obtained from a single patient sample using a vitros 5600 integrated system.A likely assignable cause for the lower than expected vitros phyt results could not be determined, however, an unexpected instrument or a reagent issue cannot be ruled out as contributing factors.In addition, pre-analytical sample processing could not be ruled out as a contributing factor.Cellular debris, due to poor sample preparation, may have been present in the affected sample, although this could not be confirmed.The definitive assignable cause for the event is unknown.

Event Description

The customer observed multiple, non-reproducible, lower than expected vitros phyt results obtained from a single patient sample processed on a vitros 5600 integrated system.Patient phyt:7.5, 9.6, 8.5, 8.5 and 9.3 ug/ml versus expected 12.0ug/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The lower than expected vitros tropi es results associated with patient 1 were not reported from the laboratory.There was no allegation of patient harm as a result of the event.This report is number three of five mdr's for this event.Five 3500a forms are being submitted for this event as five devices were involved.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS PHYT REAGENT
• 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: 5676693
• MDR Text Key: 46218976
• Report Number: 1319809-2016-00073
• 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: 05/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Catalogue Number: 8298671
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/28/2016
• Initial Date FDA Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2015
• 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