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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected vitros amon result was obtained when a non-vitros (mas) qc fluid was processed using vitros amon slides lot#: 1018-0254-1427 on a vitros 5600 integrated system.A definitive cause of the lower than expected vitros amon result was not established.A vitros amon lot#: 1018-0254-1427 issue cannot be ruled out as a contributor to the event, as qc results around the time of the event were unacceptable in terms of precision.Specifically, the vitros amon results from both levels of mas qc fluids leading up to the event on were lower than the respective baseline means.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#: 1018-0254-1427.Mas qc results were acceptable when the mas qc fluids were tested using vitros amon slide lot#: 1018-0254-4043, however, there were insufficient number of results to evaluate the overall performance of vitros amon slide lot#: 1018-0254-4043 in combination with the vitros 5600 system.An instrument issue cannot be ruled out as a contributor to the event as the acceptable within run vitros amon precision test was not performed closer to the date of the event.It is possible a transient instrument issue contributed to the event on (b)(6) 2020.Improper sample handling protocol by the customer cannot be ruled out as contributing to the event.The customer did not provide any information concerning the sample handling protocols used when processing the mas quality control fluids, therefore, it is unknown if the customer is using good laboratory practices when processing the quality controls.(b)(6).

Event Description

The customer reported that a lower than expected vitros amon result was obtained when a non-vitros (mas) quality control (qc) fluid was processed using vitros amon slides lot#: 1018-0254-1427 on a vitros 5600 integrated system.Mas l2, lot aa20112a, vitros amon result of 103.62 umol/l versus the expected result (baseline mean) of 136.0 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 customer obtained the lower than expected results when processing a non-patient fluid.There was no indication patient results were affected around the time of the event.However, the investigation could not rule out patient samples would not be affected if the event were to recur.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.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; 1000 lee road; rochester NY 14606
• Manufacturer Contact: joseph falvo ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10929827
• MDR Text Key: 219351529
• Report Number: 1319809-2020-00168
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: 1726926
• Device Lot Number: 1018-0254-1427
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2020
• 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