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

Catalog Number 1912997

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined higher than expected tsh results were obtained from 2 samples from the same patient processed using vitros tsh reagent on a vitros 5600 integrated system.Investigation of this event concluded the most likely assignable cause of the repeatable, higher than expected vitros tsh results is the presence of heterophilic antibodies in the patient samples.The assignable cause was determined to be a patient sample issue related to heterophilic antibody interference.Per the vitros tsh instructions for use, heterophilic antibodies in serum or plasma samples may cause interference in immunoassays.The customer treated the sample from the patient with a hbt blocking tube and obtained the expected tsh result confirming there is a heterophilic interferent in the patient sample that impacts the vitros tsh assay.A review of historical quality control results confirmed vitros tsh lot 6375 was performing as expected.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros product tsh, lot 6375.In addition, there was no indication of an instrument malfunction.Email address for contact office in field (b)(4).

Event Description

The customer observed reproducible, higher than expected vitros tsh results from two different samples collected from the same patient, processed on a vitros 5600 system.Sample 1 tsh result of 36.40 miu/l vs.The expected result of 0.923 miu/l obtained from a non-vitros system.Sample 2 tsh results of 37.2 and 32.9 miu/l vs.The expected result of 0.743 miu/l obtained from a non-vitros system.Biased results of the direction and magnitude observed could lead to inappropriate physician action.The higher than expected vitros tsh results were reported from the laboratory.However, the tsh results were questioned by a physician and repeat testing was performed using an alternate method.There were no allegations of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TSH 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: laurie o'riordan ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 11495586
• MDR Text Key: 241083869
• Report Number: 3007111389-2021-00036
• 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: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2021
• Device Catalogue Number: 1912997
• Device Lot Number: 6375
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2020
• 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