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

Catalog Number 1912997

Device Problem Low Test Results (2458)

Patient Problem Test Result (2695)

Event Date 03/01/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that a lower than expected vitros thyroid stimulating hormone (tsh) result was obtained when processing a single patient sample using vitros immunodiagnostics products tsh reagent lot 6060 in combination with a vitros 5600 integrated system.The result was lower than expected when compared to a result from a non-vitros roche system.A definitive assignable cause could not be determined for the lower than expected patient sample result.Based on historical quality control results, a vitros tsh lot 6060 performance issue is not a likely contributor to the event and there was no indication the vitros tsh reagent or the vitros 5600 integrated system malfunctioned in any way.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros tsh reagent lot 6060.A possible cause for the lower than expected vitros tsh patient sample result is an unknown sample specific interferent present in the patient sample.However, the customer failed to provide when requested any additional testing results using appropriate blocking tubes.Therefore, the presence of an unknown sample interferent cannot be completely ruled out as cause of the event.Additionally, the ortho tsc established that the patient was in receipt of a multivitamin supplement.However, the patient was not knowingly taking a biotin supplement that could affect the vitros tsh result.

Event Description

A customer reported a lower than expected vitros thyroid stimulating hormone (tsh) result obtained when processing a single patient sample using vitros immunodiagnostics products tsh reagent in combination with a vitros 5600 integrated system.The result was lower than expected when compared to a result from a non-vitros roche system.Patient sample result of 0.454 miu/l (hyperthyroid) versus the expected result of 0.74 miu/l (euthyroid).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 result was not reported from the laboratory.There was no allegation of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (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: 9940882
• MDR Text Key: 229013553
• Report Number: 3007111389-2020-00036
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: AE
• 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: 04/08/2020

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: 08/12/2020
• Device Catalogue Number: 1912997
• Device Lot Number: 6060
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 04/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2019
• 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