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

Catalog Number 1726926

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros amon results were obtained from vitros performance verifier quality control fluids using vitros amon reagent on a vitros 5600 integrated system.A definitive assignable cause of the event was not established.However, the most likely cause of the event is day to day inconsistencies with quality control fluid handling.Acceptable within run amon and alkp precision test results indicate the vitros 5600 system is performing as expected and is not a contributor of the event or the unacceptable quality control within laboratory precision.The historical vitros amon quality control results indicate unacceptable within laboratory precision.However, acceptable within run amon precision test results verified the system performance; therefore, day to day inconsistencies with fluid handling is the likely cause of the observed imprecision and the higher than expected vitros amon results.In addition, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros amon slides lot 1018-0253-8819.

Event Description

A customer contacted ortho clinical diagnostics (ortho) global technical support center (tsc) to report higher than expected amon (ammonia) results obtained when processing quality control fluids on a vitros 5600 integrated system.Vitros liquid performance verifier i lot k7186.Vitros amon result of 95.73* umol/l versus the expected vitros amon result of 45.2 umol/l.Vitros liquid performance verifier ii lot j6667 vitros amon result of 225.80* umol/l versus the expected vitros amon result of 186.9 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 amon results were obtained when processing a quality control fluid.Ortho was not made aware of any allegation of patient harm due to the event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).This report is number 2 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.

• Brand Name: VITROS CHEMISTRY PRODUCTS AMON 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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10236043
• MDR Text Key: 241567254
• Report Number: 1319809-2020-00069
• Device Sequence Number: 1
• Product Code: JID
• 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: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Catalogue Number: 1726926
• Device Lot Number: 1018-0253-8819
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1