MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS NA+ SLIDES; IN-VITRO DIAGNOSTICS

Model Number 8379034

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/21/2023

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected sodium result was obtained from a college of american pathologists (cap) proficiency sample repeat processed using vitros chemistry products sodium (na+) slides lot 4211-1096-5681 on a vitros xt 7600 integrated system.Cap chm-07 na+ result of 135.8 mmol/l versus the expected result of 129.8 biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The unexpected result was from a proficiency sample repeat.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number: (b)(4) and reportability assessment: 603169.

Manufacturer Narrative

The investigation determined that a higher than expected sodium result was obtained from a college of american pathologists (cap).Proficiency sample repeat processed using vitros chemistry products sodium (na+) slides, lot 4211-1096-5681 on a vitros xt 7600 integrated system.The assignable cause of the event cannot be determined.An issue with the age of the cap sample cannot be ruled out as a contributor to the event.Per cap, opened specimens are stable at 2-8 degrees celsius for 7 days.The customer initially processed the sample in june 2023 and repeated the sample in august 2023, obtaining the higher than expected result above.Historical quality control results for vitros na+ lot 4211-1096-5681 showed some imprecision at higher concentrations, however current performance was within expectation, indicating that a vitros na+ lot 4211-1096-5681 performance issue is not a likely contributor to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros na+ lot 4211-1096-5681.As precision testing was not run at the time of the event, an instrument related issue could not be confirmed nor ruled out as a contributing factor of the events.

• Brand Name: VITROS CHEMISTRY PRODUCTS NA+ SLIDES
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 17760554
• MDR Text Key: 324142770
• Report Number: 0001319809-2023-00105
• Device Sequence Number: 1
• Product Code: JGS
• UDI-Device Identifier: 10758750004812
• UDI-Public: 10758750004812
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2024
• Device Model Number: 8379034
• Device Catalogue Number: 8379034
• Device Lot Number: 4211-1096-5681
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1