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

Catalog Number 1387000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher and lower than expected quality control results were obtained from vitros free thyroid control lot 460 processed using vitros tsh reagent lot 6395 and vitros ft4 reagent lot 4600 in combination with a vitros xt7600 integrated system.The definitive assignable cause of the event was not determined.Ongoing tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with this vitros tsh lot 6395 and ft4 lot 4600.Pre-analytical sample mixup cannot be ruled out as a potential contributor to the event as the level 1 & 3 results obtained for both tsh and ft4 are similar in concentration to the ftc level 2 package insert means.However, the customer declined this conclusion indicating that they tried fresh qc and the results were still unacceptable until they ran the qc on alternate tsh and ft4 reagent lots.The customer reported that due to this issue they discarded all ftc level 2 vials which could infer the wrong qc level was processed, but this could not be confirmed.A review of historical quality control results for both tsh lot 6395 and ft4 lot 4600 indicate acceptable performance up until 29 april 2021 when they reported the unacceptable ftc results.There was no indication that the vitros xt7600 integrated system malfunctioned.Within run precision testing was conducted around the time of the event to verify instrument performance and acceptable results were obtained confirming an instrument issue was not a likely contributor to the event.Email address for contact office is (b)(4).

Event Description

The investigation determined that higher and lower than expected quality control results were obtained from vitros free thyroid control lot 460 processed using vitros thyroid stimulating hormone (tsh) reagent lot 6395 and vitros ft4 reagent lot 4600 in combination with a vitros xt7600 integrated system.(b)(6).Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected.The lower and higher than expected tsh and ft4 results were obtained from quality control fluids.There was no indication that erroneous patient results were obtained or reported from the laboratory.However, the investigation cannot conclude that patient results would not be impacted if the event were to recur undetected.There was no allegation of patient harm as a result of this event.This report is number four of four mdr¿s for this event.Four 3500a forms are being submitted for this event as four devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTICS PRODUCTS 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 11888607
• MDR Text Key: 265619281
• Report Number: 3007111389-2021-00080
• 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: 05/26/2021

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: 07/29/2021
• Device Catalogue Number: 1387000
• Device Lot Number: 4600
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 05/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2020
• 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