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

Catalog Number 1912997

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/21/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros thyroid stimulating hormone (tsh) results were obtained from vitros tsh control fluids processed using vitros immunodiagnostic products tsh reagent lot 5805 on a vitros xt 7600 integrated system during internal analyzer verification testing.A definitive assignable cause could not be determined.An instrument issue with the vitros xt 7600 integrated system is not likely a contributor to the event as a new lot of both vitros tsh reagent and vitros control fluids were tested successfully yielding acceptable results on (b)(6) 2019.It was also indicated that precision and accuracy testing conducted on the vitros xt 7600 integrated system passed.However, the data was not provided.Previous internal testing conducted using vitros tsh lot 5805 and tsh control lot 0720 from (b)(6) to (b)(6) 2019 was successful having results within expectations.An issue with vitros tsh reagent lot 5805 or the vitros tsh control lot 0720 could not be either confirmed or ruled out.However, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros tsh reagent lot 5805.

Event Description

On (b)(6) 2019, an ortho review of routine internal vitros thyroid stimulating hormone (tsh) analyzer qualification data for vitros immunodiagnostic products tsh reagent lot 5805 revealed that higher than expected results had been obtained.The results were obtained on (b)(6) 2019 as part of vitros tsh quality control (qc) fluid analyzer qualification for the vitros xt 7600 integrated system.Vitros tsh control lot 0720 level 2 results of 2.98, 2.92, 2.99 and 2.98 miu/l ((b)(6) 2019) versus an expected result of 2.12 miu/l.Vitros tsh control lot 0720 level 3 results of 25.49, 25.98, 25.07, 25.04, 25.53, 25.17 miu/l (21 february 2019) and 25.73, 25.64, 25.59 miu/l ((b)(6) 2019) versus an expected result of 19.3 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 were from control fluids and obtained during internal analyzer qualification testing.All results remained under internal control and there were no allegations of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc.Non-conformance 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: 8565832
• MDR Text Key: 203368202
• Report Number: 3007111389-2019-00072
• 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: 04/30/2019

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: 09/10/2019
• Device Catalogue Number: 1912997
• Device Lot Number: 5805
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/05/2019
• Initial Date FDA Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2018
• 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