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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/03/2021

Event Type  malfunction  

Event Description

The investigation determined that a higher than expected ammonia (amon) result was obtained when the customer processed a non-vitros (mas) qc fluid using vitros amon lot 1018-0256-9804 on a vitros xt7600 integrated system.Mas lot aa22022a level 2 result of 301.835 umol/l versus the customer¿s estimated baseline mean result of 179 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 vitros amon result was obtained when the customer was processing a non-patient fluid.Ortho was not made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint (b)(4).

Manufacturer Narrative

The investigation determined that a higher than expected ammonia (amon) result was obtained when the customer processed a non-vitros (mas) quality control (qc) fluid using vitros amon lot 1018-0256-9804 on a vitros xt7600 integrated system.A definitive assignable cause of the event was not determined.An instrument issue cannot be ruled out as a contributor to the event as no diagnostic precision testing was conducted around the time of the event ((b)(6) 2021); therefore it cannot be determined whether the instrument was performing as expected when the higher than expected result was obtained.Qc results following ortho field engineer service actions performed on 13 october 2021 were acceptable in terms of amon accuracy and precision.However, since the service was over 5 weeks after the day of the event, it cannot be confirmed or ruled out if an instrument issue contributed to the event.A vitros amon lot 1018-0256-9804 issue cannot be ruled out as a contributor to the event, as historical qc results indicated unacceptable precision leading up to the event on (b)(6) 2021.However, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros amon lot 1018-0256-9804.(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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 12775238
• MDR Text Key: 285072417
• Report Number: 1319809-2021-00159
• 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: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Catalogue Number: 1726926
• Device Lot Number: 1018-0256-9804
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1