MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS BUBC SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number 1612365

Device Problem Low Test Results (2458)

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

Event Date 05/24/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported lower than expected bu patient sample results obtained from a patient sample using vitros bubc slide lot 0216-0448-8109 on a vitros xt7600 integrated system.The most likely assignable cause is user error caused by a combination of pre-analytical sample mix up and improper pre-analytical sample handling.The indices for hemolysis, icterus, turbidy (hit) from each test event were different between some of the initial and repeat test events and the customer indicated the vitros users did not use proper laboratory practice when retesting the samples, which were left uncapped and exposed to light for extended periods before retesting.Per the vitros bubc instructions for use: handle and store specimens in stoppered containers to avoid contamination and evaporation.Protect specimens from light.In vitro exposure to light may alter bilirubin chemical and spectral properties because of the formation of photobilirubin.Historic quality control results indicated vitros bubc slide lot 0216-0448-8109 was performing as intended on the vitros xt7600 integrated system, however, neither control level adequately evaluates performance of the vitros bu assay for sample with bu concentrations of those associated with this issue.Therefore, a reagent issue cannot be entirely ruled out as a contributing factor.The customer gave no indication the vitros xt7600 integrated system was not performing as intended, however, since no diagnostic within-run precision testing was performed to assess instrument function, an instrument related performance issue cannot be completely ruled out as contributing to the event.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros bubc slide lot 0216-0448-8109.Email address for contact office above is (b)(6).

Event Description

The customer reported lower than expected bu patient sample results obtained from a patient sample using vitros bubc slide lot 0216-0448-8109 on a vitros xt7600 integrated system.Patient sample vitros bu results of 15.8, 15.7 and 14.8 mg/dl vs.The expected result of 20.0 mg/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.It is unknown which vitros bu results were reported outside of the laboratory.There was no reported allegation of patient harm as a result of this event.This report is number three of three mdr¿s for this event.Three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS BUBC SLIDES
• 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; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 14856004
• MDR Text Key: 303254328
• Report Number: 1319809-2022-00041
• Device Sequence Number: 1
• Product Code: CIG
• 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: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/01/2023
• Device Catalogue Number: 1612365
• Device Lot Number: 0216-0448-8109
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2022
• 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