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

Catalog Number 1726926

Device Problem Low Readings (2460)

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

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected vitros amon result was obtained from a vitros liquid performance verifier (lpv) quality control fluid using vitros amon reagent on a vitros 5600 integrated system.A definitive assignable cause of the event was not established.A within run vitros amon precision was not processed, and it is unknown if any additional troubleshooting was performed aside from calibrating the vitros amon.Therefore, an analyzer issue cannot be confirmed or ruled out as a possible cause of the lower than expected vitros amon result.A vitros pv fluid issue is an unlikely contributor to the event, as acceptable pv results from both lpv i lot p8085 and lpv ii lot q8086 were obtained following the event.Fluid handling protocol was not provided therefore a quality control fluid handling issue cannot be ruled out as a contributor to the event.Quality control results showed unacceptable laboratory precision leading up to the day of the event but have been acceptable since the event.It is possible that day to day inconsistencies with lpv fluid handling is the cause of the unacceptable within laboratory precision, although this cannot be confirmed.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros amon slides lot 1018-0253-7843.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) global technical support center (tsc) to report lower than expected vitros amon (ammonia) results obtained when processing quality control fluids on a vitros 5600 integrated system.Vitros lpv ii lot q8086 result of 149.58 umol/l versus the expected result of 193.7 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.There was no reported allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• 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: 10602684
• MDR Text Key: 231138582
• Report Number: 1319809-2020-00112
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• 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: 1018-0253-7843
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2020
• 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