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

Catalog Number 1726926

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined higher than expected vitros amon results were obtained from vitros quality control fluids using the vitros amon slides on a vitros 350 chemistry system.A definitive assignable cause could not be determined with the information provided.The customer does not routinely perform amon testing on this analyzer.The analyzer was last used two weeks prior to the event.The customer stated that vitros amon quality control results were acceptable prior to the observed shift on (b)(6) 2017 when processing the same quality control; however no quality control results were provided to confirm and verify the performance of vitros amon lot 1015-0242-0519 in combination with the vitros 350 system.After the customer recalibrated vitros amon lot 1015-0242-0519 acceptable results were obtained, therefore a reagent issue is not a likely contributor to the event.The sample metering pump leak test failed indicating the vitros 350 system was not performing as expected.The customer performed maintenance actions to address the leak test failure; however the customer calibrated vitros amon lot 1015-0242-0519 without determining if the maintenance actions mitigated the issue.In addition, diagnostic within run precision testing was not performed to evaluate the vitros 350 system performance.Therefore an analyzer related issue could not be confirmed as the cause of the event.

Event Description

Higher than expected ammonia results were obtained from two vitros quality control fluids when using vitros ammonia (amon) slides on a vitros 350 chemistry system.Vitros lpvi (lot y5362) vitros amon results >500* and >500* umol/l versus expected vitros amon result 37.5 umol/l.Vitros lpvi (lot u4561) vitros amon result >500* umol/l versus expected vitros amon result 36.1 umol/l.Patient samples were not processed due to the higher than expected control results.However the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There was no reported allegation of patient harm as a result of this event.This report is number three of three mdr¿s for this event.Three 3500a forms are being submitted for this event as three devices were involved.(b)(4).

• Brand Name: VITROS CLINICAL CHEMISTRY PRODUCTS AMON SLIDES
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: 6857512
• MDR Text Key: 87233380
• Report Number: 1319809-2017-00170
• Device Sequence Number: 1
• Product Code: JID
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Catalogue Number: 1726926
• Device Lot Number: 1015-0242-0519
• Other Device ID Number: 10758750000012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2016
• 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