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

Catalog Number 1726926

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation concluded that lower than expected ammonia (amon) results were obtained from a vitros liquid performance verifier (lpv) processed using vitros chemistry products amon slides lot 1018-0253-3401 on a vitros 250 chemistry system.The cause of the lower than expected quality control (qc) results is unknown as the customer did not perform any requested troubleshooting to aid in the investigation of the event.Therefore, improper fluid handling or an instrument related issue due to incubator contamination cannot be ruled out as potential causes of the event.An issue with vitros amon lot 1018-0253-3401 cannot be ruled out as it was a new lot of reagent that the customer was attempting to put into use at the time of the event and there were no historical qc results to evaluate.However, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros amon lot 1018-0253-3401.

Event Description

A customer reported lower than expected ammonia (amon) results obtained from a vitros liquid performance verifier (lpv) processed using vitros chemistry products amon slides on a vitros 250 chemistry system.Vitros lpv ii lot j6667 results of 147, 136 and 142 umol/l versus the expected result of 186.8 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 lower than expected results were obtained when processing a quality control fluid.The customer did not process any patient samples.There was no allegation of patient harm as a result of this event.This report is number 3 of 3 mdr¿s for this event.Three (3) 3500a forms are being submitted for this event as 3 devices were involved.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: 10188681
• MDR Text Key: 241409245
• Report Number: 1319809-2020-00064
• Device Sequence Number: 1
• Product Code: JID
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• 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: 1018-0253-3401
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2019
• 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