MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS HIGH SAMPLE DILUENT A REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number 8430373

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

The assignable cause for the lower than expected vitros tsh results was an incorrect value for the tsh baseline concentration for vitros hsda lot 2190 on the assay data disk (add) / mag card.It was determined that the baseline tsh concentration for hsda lot 2190 was incorrectly defined in the add/mag card as 112 miu/l instead of 0.112 miu/l.The baseline tsh concentration is subtracted out of the final numerical tsh result when an on-board dilution is performed.The incorrect hsda value (112 miu/l versus 0.112 miu/l) impacted the calculated tsh result leading to negatively biased tsh results when the sample was diluted.(b)(4).

Event Description

The investigation determined that lower than expected tsh results were obtained from a non-patient micro audit calibration verification fluid when tested using an on-board 2x dilution when compared to the tsh result tested undiluted using vitros tsh reagent lot 6610 on two different vitros 5600 systems.Tsh 2x diluted results of 9.48 and 11.8 miu/l versus undiluted tsh result of >100 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 lower than expected vitros tsh results were obtained from a non-patient micro audit calibration verification fluid.If the event were to recur with patient samples it would be anticipated that the discordancy between the undiluted and diluted results would be detectable upon result review.The customer made no indication patient sample results were affected and there was no allegation of patient harm as a result of this event.This report is number one of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

Manufacturer Narrative

Ortho has reported this as a class iii recall to oradevices1recalls@fda.Hhs.Gov on 22 november 2021.A communication (cl2021-287) was sent on 22 november 2021 to customers who have been shipped vitros high sample diluent a (hsda) lot 2190.The communication advised customers of the issue with lower than expected tsh results when using hsda lot 2190 for onboard dilution and advised that vitros hsda lot 2190 be discontinued to dilute samples tested with vitros tsh reagent.The communication indicates that if their facility does not use the vitros tsh assay, they may continue to use the vitros hsda lot 2190.However, if their facility does use the vitros tsh assay, ortho will replace their inventory of hsda lot 2190.

Event Description

This supplemental mdr report was created to document this event was reported as a class iii recall and a communication was sent to customers.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS HIGH SAMPLE DILUENT A 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 12865452
• MDR Text Key: 282116921
• Report Number: 3007111389-2021-00152
• Device Sequence Number: 1
• Product Code: PPM
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

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: 05/09/2022
• Device Catalogue Number: 8430373
• Device Lot Number: 2190
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/23/2021
• Supplement Dates Manufacturer Received: 10/29/2021
• Supplement Dates FDA Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1