MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 REAGENT PACK; IN-VITRO DIAGNOSTIC

Catalog Number 1387000

Device Problem Low Test Results (2458)

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

Event Date 07/05/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation has confirmed that lower than expected vitros ft4 results were obtained from a patient sample correlation performed between two vitros users using a vitros immunodiagnostic products ft4 reagent lot 4060 on a vitros 5600 integrated system.A definitive assignable cause for the lower than expected vitros ft4 results could not be determined.Based on historical quality control results, a vitros ft4 lot 4060 performance issue is not a likely contributor to the event.Additionally, there is also no indication of an instrument malfunction and unexpected instrument performance is not a likely contributor to the event as precision testing performed on the instrument was within ortho guidelines.Furthermore, pre-analytical sample processing could not be ruled out as a contributing factor, as it was established that the customer was not following the sample collection device manufacture¿s recommendation for sample centrifugation.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.The assignable cause is unknown.

Event Description

A customer reported lower than expected vitros ft4 results obtained from a patient sample correlation performed between two vitros users using a vitros immunodiagnostic products ft4 reagent lot 4060 on a vitros 5600 integrated system.Patient sample 3 result of 1.95 ng/dl vs.The expected result of 2.57 ng/dl.Patient sample 10 result of 1.77 ng/dl vs.The expected result of 2.30 ng/dl.Biased results of the direction and magnitude observed may lead to inappropriate physician action.The vitros ft4 results were reported from the customer¿s laboratory.However, no treatment was altered, initiated or stopped based on the reported results and ortho has not been made aware of any allegation of patient harm as a result of this event.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 REAGENT PACK
• 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; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 7736457
• MDR Text Key: 115675521
• Report Number: 3007111389-2018-00120
• Device Sequence Number: 1
• Product Code: CEC
• 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: 07/31/2018

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: 01/01/2019
• Device Catalogue Number: 1387000
• Device Lot Number: 4060
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 07/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2018
• 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