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

Catalog Number 8298671

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 03/18/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower and higher than expected vitros phyt results were obtained from vitros tdm control fluids using a vitros 5600 integrated system.A definitive assignable cause for the event could not be determined.The vitros 5600 integrated system can be ruled out as a contributing factor since the within precision performance testing was within expectations.An unknown issue with the phyt reagent is the most likely assignable cause as the issue was resolved with a new lot of phyt reagent.(b)(4).

Event Description

The customer obtained lower and higher than expected vitros phyt quality control results (vitros tdm n3998 = 11.8, 11.4 and 8.1 versus expected 15.05 ug/ml; tdm p3999 = 14.4, 32.7 and 32.8 versus expected 26.7 ug/ml) processed using a vitros 5600 integrated system.Biased results of the direction and magnitude observed may lead to inappropriate physician action.Although there were no reports of affected patient sample results, it cannot be confirmed that patient sample results were not affected and would not be affected if the event were to recur undetected.There were no allegations of patient harm.This report is number one of six mdr's for this event.Six 3500a forms are being submitted for this event as six devices were involved.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS PHYT SLIDES
• Type of Device: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 513 technology blvd.; rochester NY 14652
• 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: 5641035
• MDR Text Key: 46183276
• Report Number: 1319809-2016-00044
• Device Sequence Number: 1
• Product Code: DIP
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/09/2016

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
• Device Lot Number: 2614-0157-8570
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/12/2016
• Initial Date FDA Received: 05/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2015
• 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