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

Catalog Number 1912997

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

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

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a higher than expected vitros tsh result was obtained from a patient sample during a patient correlation which was processed as part of troubleshooting using vitros tsh reagent lot 6180 on a vitros 5600 integrated system.The most likely assignable cause of the higher than expected patient sample result is an issue related to pre-analytical sample handling.It was confirmed that several of the patient samples processed including patient sample 9 were not re-centrifuged before being re-processed using vitros tsh lot 6180 and the serum was likely not separated from the cellular material.However, an issue related to pre-analytical handling could not be entirely confirmed.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros tsh reagent lots 6180.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report a higher than expected thyroid stimulating hormone (tsh) patient sample result obtained from vitros immunodiagnostic products tsh reagent on a vitros 5600 integrated systems.Patient sample 9 vitros tsh result of 3.08* miu/l vs the expected result of 1.83 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 tsh results was not reported from the laboratory.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 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: 10491030
• MDR Text Key: 208378509
• Report Number: 3007111389-2020-00118
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2020
• Device Catalogue Number: 1912997
• Device Lot Number: 6180
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2020
• 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