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 02/14/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation concluded that higher than expected ammonia results were obtained from samples from two different patients using vitros chemistry products amon slides lot 1018-0252-2336 on a vitros 5600 integrated system.The investigation was unable to determine a definitive assignable cause for this event.However, a sample related issue related to the affected patients or a transient issue affecting the vitros amon slides in use at the time of the event cannot be ruled out.The issue is isolated only to samples drawn from the affected patients in question, as other patient samples run over this time frame did not demonstrate a similar issue.Historical quality control results exhibited some within-laboratory imprecision, but not to the magnitude observed with the affected samples.In addition, a vitros amon within-run precision test had results within acceptable guidelines indicating vitros amon reagent lot 1018-0252-2336 was performing as intended on the vitros 5600 integrated system.Continual tracking and trending of complaint data does not indicate a potential systemic issue with vitros amon lot 1018-0252-2336.

Event Description

A customer reported higher than expected ammonia (amon) results obtained from samples from two different patients processed using vitros chemistry products amon slides on a vitros 5600 integrated system.Patient 1 vitros amon results of 143.4 and 246.1 umol/l vs.The expected result of 101.2 umol/l.Patient 2 vitros amon results of 111.9 and 216.6 umol/l vs.The expected result of 54.9 umol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected patient sample results were not reported outside of the laboratory and there was no allegation of patient harm as a result of this event.This report is number 1 of 4 mdr¿s for this event.Four (4) 3500a forms are being submitted for this event as 4 devices were involved.This report corresponds to ortho clinical diagnostics inc.(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: 9825005
• MDR Text Key: 225254182
• Report Number: 1319809-2020-00032
• 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: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Catalogue Number: 1726926
• Device Lot Number: 1018-0252-2336
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2019
• 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