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

Model Number 1721869

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 02/10/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros ammonia (amon) results were obtained from a single patient sample and a lower than expected quality control result was obtained from a vitros liquid performance verifier processed using vitros chemistry products amon slides lot 1019-0259-9814 on two different vitros xt 7600 integrated systems.The most likely cause of the higher than expected vitros amon patient sample result of 125 umol/l from analyzer 1 is a sample related issue due to improper protocol as the sample was likely past the stability limit at the time of testing as it had been at room temperature for longer than what is recommended in the vitros amon instructions for use.Additionally, the most likely cause of the higher than expected vitros amon patient sample results of 239, 235, 255, 251, 257 and 275 umol/l from analyzer 2 is a sample related issue due to improper protocol as the sample had been stored frozen for three days prior to these results being obtained.According to the instructions for use for vitros amon, samples that are frozen are stable for < or = 24 hours and the sample was past the stability limit at the time of testing.A definitive assignable cause of the lower than expected quality control result could not be determined.Based on historical quality control results, a vitros amon lot 1019-0259-9814 related issue cannot be ruled as a contributing factor of the event.An instrument related issue cannot be ruled out as a contributor of the event as no precision testing was performed on the vitros xt 7600 systems.Additionally, historical quality control results were imprecise on both instruments.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros amon reagent lot 1019-0259-9814.

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 a single patient sample and a lower than expected quality control result was obtained from a vitros liquid performance verifier (lpv) processed using vitros chemistry products amon slides lot 1019-0259-9814 on two different vitros xt 7600 integrated systems.Analyzer 1: patient sample result of 125 umol/l versus an expected result of 90 umol/l.Analyzer 2: patient sample results of 239, 235, 255, 251, 257 and 275 umol/l versus an expected result of 90 umol/l vitros lpv ii lot x9323 result of 153.5 umol/l versus an expected result of 195.69 umol/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 vitros amon result was from a non-patient fluid.The higher than expected vitros amon patient sample results were not reported out of the laboratory and no treatment was initiated, altered or stopped based on any vitros results.Ortho was not made aware of any allegation of patient harm as a result of this event.This report is number one 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) and reportability assessment (b)(4).

• 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: 16544606
• MDR Text Key: 311305956
• Report Number: 0001319809-2023-00020
• Device Sequence Number: 1
• Product Code: JID
• UDI-Device Identifier: 10758750009602
• UDI-Public: 10758750009602
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Model Number: 1721869
• Device Catalogue Number: 1721869
• Device Lot Number: 1019-0259-9814
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1