MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTICS PRODUCT FT4 REAGENT PACK; IN VITRO DIAGNOSTICS

Catalog Number 1387000

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/14/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected vitros ft4 result was obtained from a non-vitros biorad l2 control fluid when processed on a vitros eciq immunodiagnostics system.The investigation was unable to determine a definitive assignable cause.Based on historical vitros ft4 reagent lot 3748 quality control results there is no indication a reagent related issue contributed to the event.However, as the customer did not provide qc results for the 3 days prior to the event, an issue with the vitros ft4 reagent lot cannot be completely ruled out as a contributing factor.Due to routine maintenance actions being performed on the system prior to successful precision testing, an instrument related issue cannot be entirely ruled out as contributing to the event.The assignable case of the event is unknown.

Event Description

The investigation has determined that a lower than expected vitros ft4 result was obtained from a single level of non-vitros biorad control processed on a vitros eciq immunodiagnostics system.Biorad l2 result of 2.0 ng/dl vs.An expected result of 5.27 ng/dl.Biased results of the direction and magnitude observed could lead to inappropriate physician action.There was no report of patient samples being affected and there was no report of patient harm as a result of this event.However, the investigation could not rule out that patient samples were not, or would not be affected if the event were to recur undetected.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTICS PRODUCT FT4 REAGENT PACK
• 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; 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: 6447111
• MDR Text Key: 71587945
• Report Number: 3007111389-2017-00039
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 03/30/2017

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: 05/10/2017
• Device Catalogue Number: 1387000
• Device Lot Number: 3748
• Other Device ID Number: 10758750008971
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2017
• Initial Date FDA Received: 03/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2016
• 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