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

Catalog Number 1387000

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 10/20/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower and higher than expected vitros tsh results and higher than expected vitros ft4 results were obtained from control fluids, when compared to the package insert or customers baseline means using vitros immunodiagnostic products tsh reagent and vitros immunodiagnostic products ft4 reagent on a vitros 5600 integrated system.The most likely cause of the higher and lower than expected vitros tsh results and higher than expected vitros ft4 results are biased calibrations on (b)(6) 2021 that caused a shift in qc performance, likely caused by a compromised signal reagent pack.When typical calibrations were obtained on the reagent lots, qc fluid and patient sample results obtained were acceptable to the customer.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros tsh reagent lot 6580 or vitros ft4 reagent lot 4770.Email address for contact office above is (b)(4).

Event Description

The investigation determined that lower and higher than expected vitros tsh results and higher than expected vitros ft4 results were obtained from control fluids, when compared to the package insert or customers baseline means using vitros immunodiagnostic products tsh reagent and vitros immunodiagnostic products ft4 reagent on a vitros 5600 integrated system.Ftc lot 660 l1 ft4 results of 0.993, 0.984, 1.031 and 1.011ng/dl vs.The expected pi mean result of 0.053 ng/dl, biorad lot 85241 tsh results of 0.321, 0.3659, 0.3677, 0.3793, 0.3834, 0.9137 and 0.8868 miu/l vs.The expected mean result of 0.595 miu/l; biorad lot 85243 tsh results of 17.50, 17.96, 18.05, 18.16, 18.87, 41.07 and 41.87 miu/l vs.The expected mean result of 28.10 miu/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher than expected vitros ft4 results and the lower and higher than expected vitros tsh results were obtained from non-patient fluids.The customer did not give any indication that patient results had been affected and patient samples were not processed when the qc fluids were out of specification.There is no allegation of patient harm as a result of this event.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.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T4 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: 12829113
• MDR Text Key: 281860603
• Report Number: 3007111389-2021-00150
• 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: 11/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Catalogue Number: 1387000
• Device Lot Number: 4770
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1