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

Catalog Number 1912997

Device Problem Low Readings (2460)

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

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation confirmed that lower than expected vitros tsh results were obtained from different patient samples when tested on a vitros 5600 integrated system, using reagent lot 5775.The results were lower than expected when compared to results obtained from a non-vitros (siemens) system.A definitive assignable cause for the lower than expected vitros tsh result could not be determined.Based on historical quality control results, a vitros tsh lot 5775 performance issue is not a likely contributor to the event.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 5775.Additionally, there is also no indication of an instrument malfunction and unexpected instrument performance is not a likely contributor to the events as precision testing performed on the instrument was within ortho guidelines.

Event Description

A customer obtained lower than expected vitros tsh results from different patient samples when tested on a vitros 5600 integrated system using reagent lot 5775.The results were lower than expected when compared to results obtained from a non-vitros (siemens) system.Patient sample 1 result of 0.24 miu/l versus the expected results of 1.311 miu/l.Patient sample 5 result of 0.08 miu/l versus the expected results of 1.75 miu/l.Patient sample 6 result of 0.38 miu/l versus the expected results of 0.574 miu/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The lower than expected, vitros tsh results were reported from the laboratory.The customer informed ortho that some of the patients (specific patients were not indicated) were dosed with levothyroxine.Levothyroxine is used as replacement therapy for hypothyroidism.The lower than expected vitros tsh results would suggest the patients suffered from a hyperthyroid condition, therefore it is unlikely the levothyroxine was given in response to the lower than expected vitros tsh values.Ortho has not been made aware of any allegation of actual patient harm as a result of this event.This report is number two 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: 8271477
• MDR Text Key: 135173154
• Report Number: 3007111389-2019-00017
• 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: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2019
• Device Catalogue Number: 1912997
• Device Lot Number: 5775
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2018
• 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