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

Catalog Number 1912997

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

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

Event Date 03/31/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that lower than expected thyroid stimulating hormone (tsh) results were obtained from samples from multiple patients processed using three different lots of vitros immunodiagnostic products tsh reagent on a vitros 5600 integrated system.The results were considered lower than expected when compared to tsh results obtained from a non-vitros roche cobas system.The magnitude of bias of the vitros tsh results meets potential health and safety criteria and the results are reportable.The assignable cause for the lower than expected vitros tsh results is a sample related issue likely due to the presence of biotin.It was confirmed that several samples that produced lower than expected vitros tsh results were from patients that were taking supplements containing biotin.In addition, a second correlation using samples from 20 random patients yielded results that were concordant between the vitros and roche methods for all 20 samples.In july 2018, ortho issued a customer communication (b)(4) to alert customers that biased results may occur for specific vitros integrated products (microwell assays) at biotin concentrations which are lower than indicated in the current instructions for use (ifu).Based on historical quality control results, a vitros tsh reagent performance issue is not a likely contributor to the event.There was no indication of an instrument malfunction and unexpected instrument performance is not a likely contributor to the event.Vitros tsh within run precision testing results from the vitros 5600 system were within ortho acceptable guidelines.However, the precision testing did not occur around the time of the initial event.Therefore, an instrument related issue cannot be completely ruled out as a contributing factor of the event.In addition, pre-analytical sample processing could be entirely ruled out as a contributing factor, as it is unknown if the sample collection device manufacturer¿s recommendation for sample centrifugation was being followed.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.Per a medical consult with an ortho medical safety officer: patients may experience sub-optimally controlled thyroid disease or potentially the side effects of changed medication or increase dose of medicine.However, patients who are under treatment of thyroid diseases, thyroid function tests are often ordered regularly to monitor treatment effects.Serious injuries due to altered thyroid medication is unlikely.Email address for contact office in field is (b)(4).

Event Description

A customer obtained lower than expected thyroid stimulating hormone (tsh) results from samples from multiple patients processed using three different lots of vitros immunodiagnostic products tsh reagent on a vitros 5600 integrated system.The results were considered lower than expected when compared to tsh results obtained from a non-vitros roche cobas system.The magnitude of bias of the vitros tsh results meets potential health and safety criteria and the results are reportable.Lot 6430: patient 3 vitros tsh result of <0.015* miu/l vs the expected result of 1.3 miu/l.Patient 4 vitros tsh result of 0.99* miu/l vs the expected result of 1.6 miu/l.Lot 6470: patient 5 vitros tsh result of 0.09* miu/l vs the expected result of 0.31 miu/l.Patient 8 vitros tsh result of 0.15* miu/l vs the expected result of 0.31 miu/l.Patient 10 vitros tsh result of 2.37* miu/l vs the expected result of 5.9 miu/l.Lot 6480: patient 11 vitros tsh result of 0.036* miu/l vs the expected result of 1.1 miu/l patient 13 vitros tsh result of 0.014* miu/l vs the expected result of 1.1 miu/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected vitros tsh patient sample results were reported from the laboratory.A physician later questioned the results, however, based on the lower than expected results thyroid medications had been altered for several patients.The physician did not provide any further specific details regarding the altered treatments or medications.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number six of seven mdr¿s for this event.Seven 3500a forms are being submitted for this event as seven devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TSH 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: 11886491
• MDR Text Key: 266241764
• Report Number: 3007111389-2021-00075
• Device Sequence Number: 1
• Product Code: JLW
• 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

• Date FDA Received: 05/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Catalogue Number: 1912997
• Device Lot Number: 6480
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2021
• 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