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 Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that discordant, higher than expected vitros tsh results were obtained from multiple patient samples using vitros immunodiagnostics products tsh reagent lot 6000 tested on a vitros 5600 integrated system.The results were discordant when compared to results obtained from a non-vitros abbott system.A definitive assignable cause for the higher than expected vitros tsh results could not be determined.However, it is likely that a combination of insufficient instrument maintenance, pre-analytical sample handling and the failure to follow instructions in regards to using within-date reagents contributed to the event.The customer had not run vitros maintenance packs when scheduled, as em (expired maintenance) test codes posted for all vitros tsh results between 19 october 2019 and 11 november 2019.In addition, re (reagent expired) test codes were posted during the testing of two of the patient samples indicating an expired reagent was in use on the vitros 5600 integrated system.Additionally, pre-analytical sample handling cannot be ruled out as a contributor to the event as the ortho technical solutions center indicated that the discordant, higher than expected vitros tsh results were obtained more than 7 days after sample collection.The vitros tsh instructions for use (ifu) states: ¿serum and plasma samples may be stored for up to 7 days at 2¿8 °c or 4 weeks at -20 °c¿.There was no indication that any of the patient samples had been frozen.A reagent issue cannot be ruled out as a contributor to the event as no historical quality control results were available to verify the performance of the vitros tsh lot 6000 reagent.However, ongoing tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros tsh reagent lot 6000.The performance of the vitros 5600 integrated system was not verified around the time of the event and cannot be ruled out as a contributing factor of the event.No precision testing was conducted on the instrument, however, cleaning actions appeared to have resolved the issue.No specific details of the cleaning actions performed were provided by the customer.

Event Description

A customer reported discordant, higher than expected vitros tsh results obtained from multiple patient samples processed using vitros immunodiagnostics products tsh reagent in combination with a vitros 5600 integrated system.The results were discordant when compared to results obtained from a non-vitros abbott system.Patient 1 result of 86.4 miu/l versus the abbott result of 49.0 miu/l.Patient 2 result of 1.12 miu/l versus the abbott result of 0.67 miu/l.Patient 3 result of 3.37 miu/l versus the abbott result of 2.05 miu/l.Patient 4 result of 33.2 miu/l versus the abbott result of 18 miu/l.Patient 6 result of 21.7 miu/l versus the abbott result of 12.6 miu/l.Patient 7 result of 39.3 miu/l versus the abbott result of 23 miu/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros tsh results were 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 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: 9482116
• MDR Text Key: 219213301
• Report Number: 3007111389-2019-00204
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: LE
• 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: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2020
• Device Catalogue Number: 1912997
• Device Lot Number: 6000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2019
• 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