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 09/07/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros chemistry products amon slide lot 1018-0254-0463 results were obtained from biorad lot 54320 quality control fluids on a vitros 5600 integrated system.The assignable cause of the event was not determined.A review of quality control performance prior to the event indicated the amon accuracy was higher than peer and there was some imprecision observed.However, the magnitude of suboptimal qc precision and accuracy observed with historical qc was not similar to the significant shift in accuracy and precision that the customer observed for the time interval in question.Therefore, a vitros amon lot 1018-0254-0463 issue was not a likely contributing factor but could not be completely ruled out.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros amon slides lot 1018-0254-0463.The customer did not do any of the troubleshooting recommendations provided by ortho but instead discontinued running vitros amon for approximately 3 weeks.The customer began qc testing again and acceptable performance has been maintained.Ortho was unable to further investigate how the issue was resolved as the customer declined to further follow up.Therefore, the assignable cause of the event was not determined.An instrument issue as well as qc handling & storage could not be ruled out as potential contributing factors to this event.Email address for contact office is (b)(4).

Event Description

The customer reported that higher than expected vitros chemistry products amon slide lot 1018-0254-0463 results were obtained from biorad lot 54320 quality control fluids on a vitros 5600 integrated system.Biorad level 2 = 99.3, 103.9, 120.4, 113.2, 131.4, 123.9, 155.2 versus expected 82.5 umol/l.Biorad level 3 = 296.6, 280.6, 306.9, 289.4, 324.9, 334.4 versus expected 227.8 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.There were no erroneous amon patient results reported from the laboratory.However, the investigation cannot conclude that patient results would be not affected if the event were to recur undetected.There was no allegation of patient harm as a result of this event.This report is number 1 of 13 mdr¿s for this event.Thirteen (13) 3500a forms are being submitted for this event as 13 devices were involved.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; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: joseph falvo ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10875117
• MDR Text Key: 249655821
• Report Number: 1319809-2020-00138
• 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: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Catalogue Number: 1726926
• Device Lot Number: 1018-0254-0463
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2020
• 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