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 07/11/2022

Event Type  malfunction  

Event Description

The investigation has determined that a lower than expected vitros tsh result was obtained from a patent sample when tested on a vitros 5600 integrated system using reagent lot 6680 when compared to repeat vitros tsh results for the patient.Patient 1 result of 0.342 miu/l (hyperthyroid) versus repeat (diluted) results of 105.507 and 101.724 miu/l (hypothyroid) biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower than expected vitros tsh result was 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 corresponds to ortho clinical diagnostics inc (ortho) complaint number 32179603 and ivd 510538.

Manufacturer Narrative

The investigation has determined that a lower than expected vitros tsh result was obtained from a patent sample when tested on a vitros 5600 integrated system using reagent lot 6680 when compared to repeat vitros tsh results for the patient.The definitive assignable cause for the lower than expected vitros tsh result 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.The vitros tsh result of 105.507 and 101.724 miu/l were obtained when an alternate lot of hsda was in use.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros tsh reagent lot 6770.Email address for contact office in manufacture site is (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: 15178280
• MDR Text Key: 304976401
• Report Number: 3007111389-2022-00073
• Device Sequence Number: 1
• Product Code: PPM
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2022

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
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 08/05/2022
• 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