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

Catalog Number 1912997

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined higher than expected results were obtained from three different patient samples when tested using vitros tsh reagent lot 6215 on two different vitros 5600 integrated systems.A definitive cause for the higher than expected patient sample results was not established.A vitros tsh lot 6215 reagent issue cannot be ruled out as a contributor to the event, as the results for the same patients were as expected when tested using vitros tsh lot 6170.However, the quality control results on the day of the event were acceptable indicating acceptable vitros tsh lot 6215 reagent performance.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 6215.Improper pre-analytical sample handling could have contributed to the higher than expected vitros tsh patient sample results.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.An instrument issue cannot be ruled out as a contributor to the event.No precision testing was conducted on the instruments; therefore the performance of the instruments was not verified and cannot be ruled out as a contributor to the event.No information was provided regarding instrument maintenance, therefore it could not be determined whether the customer was performing maintenance according to protocol.It is possible the customer was not performing adequate maintenance on the instruments, which could lead to issues with vitros tsh results.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report higher than expected vitros tsh results obtained from three different patient samples when tested using vitros tsh reagent lot 6215 on two different vitros 5600 integrated systems.The vitros tsh lot 6215 patient sample results were deemed higher than expected when compared to results obtained from vitros tsh lot 6170 testing.The vitros tsh lot 6215 patient sample results were deemed higher than expected when compared to results obtained from vitros tsh lot 6170 testing.J1 ¿ (b)(6), patient a results of 0.35 and 0.154 miu/l (lot 6215) versus the vitros tsh lot 6170 result of 0.06 miu/l.J2 ¿ (b)(6), patient a result of 0.159 miu/l (lot 6215) versus the vitros tsh lot 6170 result of 0.06 miu/l.J1 ¿ (b)(6), patient b result of 0.131 miu/l (lot 6215) versus the vitros tsh lot 6170 result of 0.06 miu/l.J1 ¿ (b)(6), patient c result of 0.102 miu/l (lot 6215) versus the vitros tsh lot 6170 result of 0.28 miu/l.J2 ¿ (b)(6), patient c result of 0.49 miu/l (lot 6215) versus the vitros tsh lot 6170 result of 0.28 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 patient sample results were not reported from the laboratory and ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number 2 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT
• 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: 10314896
• MDR Text Key: 243710397
• Report Number: 3007111389-2020-00081
• 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: 07/23/2020

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: 02/22/2021
• Device Catalogue Number: 1912997
• Device Lot Number: 6215
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2020
• 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