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

Catalog Number 1912997

Device Problem High Readings (2459)

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

Event Date 09/07/2019

Event Type  malfunction  

Manufacturer Narrative

A customer obtained higher than expected vitros tsh results from an institute for quality management in healthcare (iqmh) proficiency fluid when tested using two different lot of vitros tsh reagent on a vitros 5600 integrated system.The cause of the higher than expected vitros tsh results cannot be determined.Historical vitros tsh lot 5900 quality control results indicate acceptable performance.However, the customer does not process a designated tsh quality control fluid at a similar concentration as the proficiency fluid.In addition, the customer obtained an acceptable tsh result when processing the fresh proficiency sample using a different vitros tsh lot, therefore a reagent issue involving vitros tsh lot 5900 cannot be ruled out as a contributor of the event.Furthermore, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros tsh reagent lot 5900 or vitros tsh reagent lot 5945.A within run tsh precision test was not performed at the time the proficiency sample was processed to evaluate the performance of the vitros 5600 system.However, historical quality control results do not indicate an issue with precision therefore a vitros 5600 system issue is not a likely contributor of the event.The customer did not provide sample handling details.It is possible the customer did not handle the vial 1 sample as per the proficiency suppliers¿ instructions.The customer obtained a similar result when reprocessing the sample, therefore a sample related issue cannot be ruled out as a contributor of the event.

Event Description

A customer obtained higher than expected vitros tsh results from an institute for quality management in healthcare (iqmh) proficiency fluid when tested using two different lots of vitros tsh reagent on a vitros 5600 integrated system.Iqmh 1009-1 (sample 1), vitros tsh lot 5900 results of 0.28, and 0.24 miu/l versus the expected vitros tsh result 0.12 miu/l.Iqmh 1009-1 (sample 2), vitros tsh lot 5945 result of 0.18 miu/l versus the expected vitros tsh result 0.12 miu/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The higher than expected vitros tsh results were obtained when the customer was processing non-patient fluids.However, the investigation cannot confirm that patient sample results were not affected or would not be affect if the results were to recur undetected.There was no allegation of actual patient harm as a result of this event.This report is number one of three mdr¿s for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 9306149
• MDR Text Key: 220751977
• Report Number: 3007111389-2019-00172
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2020
• Device Catalogue Number: 1912997
• Device Lot Number: 5900
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2019
• 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