MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS AMON SLIDES; IN-VITRO DIAGNOSTICS

Catalog Number 1721869

Device Problem High Test Results (2457)

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

Event Date 06/08/2022

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros ammonia (amon) results were obtained from cap proficiency fluids processed using vitros chemistry products amon slides on two different vitros 5600 integrated systems.For (b)(6) 2022 on j1: chm-06 result of 437 umol/l vs an expected result of 312.9 umol/l chm-07; result of 290 umol/l vs an expected result of 215.9 umol/l chm-08; result of 299 umol/l vs an expected result of 219.6 umol/l chm-09; result of 464 umol/l vs an expected result of 334.1 umol/l chm-10; result of 284 umol/l vs an expected result of 215.9 umol/l.For (b)(6) 2022 on j1: chm-11 result of 394 umol/l vs an expected result of 309.7 umol/l chm-12; result of 577 umol/l vs an expected result of 452.2 umol/l chm-13; result of 446 umol/l vs an expected result of 345.2 umol/l chm-14; result of 188 umol/l vs an expected result of 156.0 umol/l chm-15 result of 424 umol/l vs an expected result of 339.3 umol/l.For (b)(6) 2023 on j2: chm-02 result of 443 umol/l vs an expected result of 368.0 umol/l chm-04; result of 375 umol/l vs an expected result of 312.5 umol/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 higher than expected vitros amon results were obtained when processing proficiency fluids.The customer did not state whether any patient sample results had been affected.There were no allegations of patient harm as a result of these events.This report is number eleven of twelve mdr¿s for this event.Twelve 3500a forms are being submitted for this event as twelve devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(6).

Manufacturer Narrative

The investigation determined that higher than expected vitros ammonia (amon) results were obtained from cap proficiency fluids processed using vitros chemistry products amon slides on two different vitros 5600 integrated systems.The assignable cause of the event was not able to be determined.As no quality control results were available for review, a reagent related issue cannot be ruled out as a contributor of the events.As no precision testing was performed on the vitros 5600 systems around the time of the events, an instrument related issue cannot be ruled out as a contributing factor of the events.The customer¿s protocol for preparing and handling the cap sample fluids is unknown and a sample related issue cannot be ruled out as a contributor of the events.Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros amon.

• Brand Name: VITROS CHEMISTRY PRODUCTS AMON SLIDES
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 17760240
• MDR Text Key: 324039917
• Report Number: 0001319809-2023-00115
• Device Sequence Number: 1
• Product Code: JID
• UDI-Device Identifier: 10758750009602
• UDI-Public: 10758750009602
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1721869
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1