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

Catalog Number 8298671

Device Problem Low Test Results (2458)

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

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that two lower than expected vitros phyt results were obtained from a non-vitros quality control sample using a vitros 5600 integrated system.A definitive assignable cause for the event could not be determined.Sample programming or analytical sample mix-up errors cannot be confirmed or ruled out as contributing factors.The customer was satisfied with the performance of the vitros phyt reagent lot and declined further investigation of the event.The definitive assignable cause for the event is unknown.

Event Description

The customer obtained two lower than expected phyt quality control results using a vitros 5600 integrated system (units are g/ml): qc l3 vitros results of 11.7 and 10.9 g/ml versus expected value of 20.84 g/ml biased results of the direction and magnitude observed could lead to inappropriate physician action.There was no report that patient samples were affected and no allegation of patient harm as a cause of this event.However, the investigation cannot conclude that patient samples would not be affected if the event were to recur undetected.This report is number two of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS PHYT 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: 6348787
• MDR Text Key: 68407319
• Report Number: 1319809-2017-00018
• 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: 02/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/15/2017
• Device Catalogue Number: 8298671
• Device Lot Number: 2614-0161-5584
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2016
• 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