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

Catalog Number 6801756

Device Problem Low Test Results (2458)

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

Event Date 06/21/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros psa results were obtained from biorad qc fluid lot 85302 level 2, when compared to the customer¿s baseline mean, using a vitros psa reagent on a vitros 5600 integrated system.A definitive assignable cause for the lower than expected vitros psa results could not be determined with the information provided.However, an unknown event that affected the calibrator 2 level on the (b)(6) 2022 calibration is the most likely cause of the lower than expected vitros psa results obtained.Based on historical quality control results, a vitros psa lot 4200 performance issue is not a likely contributor to the event.Additionally, there is also no indication of an instrument malfunction and unexpected instrument performance is not a likely contributor to the event.However, the customer did not perform a within run precision test at the time of the event to definitively rule out an instrument issue.Email address for contact office in field above is (b)(6).

Event Description

The investigation determined that lower than expected vitros psa results were obtained from biorad qc fluid lot 85302 level 2, when compared to the customer¿s baseline mean, using a vitros psa reagent on a vitros 5600 integrated system.Biorad immunoassay plus control level 2 results of 2.386 and 2.396 ng/ml versus an expected result of 3.22 ng/ml.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 psa results were from non-patient fluid and were not reported from the laboratory.The customer did not give any indication that patient results had been affected and there is no allegation of patient harm as a result of this event.However, the investigation cannot conclude that patient results would not be affected if the event were to occur undetected.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS PSA 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: 15051842
• MDR Text Key: 304626375
• Report Number: 3007111389-2022-00067
• Device Sequence Number: 1
• Product Code: LTJ
• 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: 07/18/2022

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: 10/03/2022
• Device Catalogue Number: 6801756
• Device Lot Number: 4200
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/22/2022
• Initial Date FDA Received: 07/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2022
• 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