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 10/21/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that higher than expected ammonia results were obtained from an american proficiency institute (api) proficiency sample using vitros chemistry products amon reagent lots 1018-0251-7488 and 1018-0252-8342 on a vitros 4600 chemistry system.The sample result was reproducible when tested at an alternate site using vitros amon reagent lot 1018-0253-3823 in combination with a vitros 350 chemistry system.The assignable cause of the event is an issue related to the api sample.The higher than expected sample result was reproducible using multiple lots of vitros amon reagent and on two different vitros instruments from two different customer sites.Based on historical quality control results a vitros amon reagent performance issue is not a likely contributor to the event.Within run precision testing performed on the vitros 4600 chemistry system was within ortho acceptable guidelines.This along with the quality control results data indicate that an issue with the vitros 4600 chemistry system is not a likely contributing factor of the event.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report higher than expected ammonia results obtained from an american proficiency institute (api) sample using vitros chemistry products amon slides on a vitros 4600 chemistry system.Vitros amon lot 1018-0251-7488 on customer vitros 4600 chemistry system: api sample 1 result of 135* umol/l versus an expected result of 101.5 umol/l, (b)(6) 2019.Vitros amon lot 1018-0252-8342 on customer vitros 4600 chemistry system: api sample 1 result of 133* umol/l versus an expected result of 101.5 umol/l, (b)(6) 2019.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 vitros amon results were from an api proficiency sample.The customer indicated that no patient sample results were affected.There have been no allegations of patient harm as a result of this event.This report is number 1 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (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: 9510322
• MDR Text Key: 214631438
• Report Number: 1319809-2019-00126
• 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: 12/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Catalogue Number: 1726926
• Device Lot Number: 1018-0251-7488
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2019
• 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