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 11/17/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation concludes that lower than expected tsh results were obtained from two different patient samples when tested using an on-board dilution using vitros hsda lot 2190 compared to the tsh obtained using a dilution using hsda lot 2180 or a manual dilution.The samples were tested using vitros tsh reagent lot 6610 on two different vitros 5600 systems.The definitive assignable cause for the lower than expected vitros tsh results was a discrepant tsh baseline concentration associated with vitros hsda lot 2190.The baseline tsh concentration is included on the assay data disk (add)/mag card and when an on-board tsh dilution is performed, the baseline tsh concentration is subtracted out before the final result is reported.An investigation performed by ortho (complaint investigation (b)(4)) determined the baseline tsh concentration for hsda lot 2190 was incorrectly defined in the add/mag card.Correct: hsda baseline tsh concentration as per certificate of analysis: 0.112 miu/l incorrect: hsda baseline tsh concentration as defined on the add: 112 miu/l.The incorrect hsda value (112 miu/l versus 0.112 miu/l) impacts the calculated tsh concentration leading to negatively biased tsh results when a sample is diluted.However, it would not be expected that this issue would go undetected, as the customer will be aware the undiluted result was above the vitros tsh measuring range of 0.015 ¿ 100 miu/l, and the diluted result was within the measuring range, indicating discordant results.Email address for contact office above is (b)(6).

Event Description

The investigation concludes that lower than expected tsh results were obtained from two different patient samples when tested using an on-board dilution using vitros hsda lot 2190 compared to the tsh obtained using a dilution using hsda lot 2180 or a manual dilution.The samples were tested using vitros tsh reagent lot 6610 on two different vitros 5600 systems.Patient sample 1 vitros tsh 5x diluted result using hsda lot 2190 of 23.1 miu/l when compared to the vitros tsh 5x diluted result using hsda lot 2180 of 469 miu/l.Patient sample 2 vitros tsh 2x diluted result using hsda lot 2190 of 2.1 miu/l when compared to the vitros tsh undiluted 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.The lower than expected patient sample 1 vitros tsh result of 23.1 miu/l was not reported outside of the laboratory and there was no allegation of patient harm as a result of this event.It is unknown if the lower than expected patient sample 2 vitros tsh result of 2.1 miu/l was reported outside of the laboratory, however, there was no reported allegation of patient harm as a result of this event.This report is number two 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).

• 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: 13011775
• MDR Text Key: 288386658
• Report Number: 3007111389-2021-00186
• 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
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• 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
• Date Manufacturer Received: 11/18/2021
• 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