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

Catalog Number 1726926

Device Problem High Test Results (2457)

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

Event Date 04/07/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation concluded that a higher than expected ammonia (amon) result was obtained from a non-vitros biorad quality control fluid using vitros chemistry products amon slides lot 1018-0253-3823 on a vitros 5600 integrated system.A definitive assignable cause could not be confirmed.Historical quality control results did not indicate an issue with vitros amon lot 1018-0253-3823.In addition, vitros control fluids performed as expected when processed on vitros amon lot 1018-0253-3823.Furthermore, 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 1018-0253-3823.Although a precision test was not performed, the vitros 5600 integrated system is not a likely contributor to the event as the issue was resolved without any actions performed on the analyzer.Additionally, pre-analytical handling of the biorad quality control fluids is unknown.Therefore, an unexpected fluid handling or another unknown issue with the biorad control fluid could not be ruled out as a contributor to the event.

Event Description

A customer reported a higher than expected ammonia (amon) result obtained from a non-vitros biorad quality control fluid processed using vitros chemistry products amon slides on a vitros 5600 integrated system.Biorad lot 54250 level 2 vitros amon result 96.44 umol/l versus the expected amon result 78.8 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 result was obtained when processing a quality control fluid and was not reported outside of the laboratory.However, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected.There was no 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: 10021280
• MDR Text Key: 216175431
• Report Number: 1319809-2020-00058
• 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: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: 1726926
• Device Lot Number: 1018-0253-3823
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2019
• 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