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

Catalog Number	8157596
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, higher than expected potassium (k+) result was obtained from a single patient sample processed using vitros chemistry products k+ slides lot 4102-1127-8062 on a vitros xt 7600 integrated system.Patient sample result of >14.00 mmol/l vs the expected result of 2.65 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The non-reproducible, higher than expected vitros k+ result was not reported from the laboratory.There has been no reported 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 (b)(4).
Additional Manufacturer Narrative
The investigation determined that a non-reproducible, higher than expected potassium (k+) result was obtained from a single patient sample processed using vitros chemistry products k+ slides lot 4102-1127-8062 on a vitros xt 7600 integrated system.A definitive assignable cause of the event could not be determined.It is unknown if historical quality control results were within expectation for vitros k+ lot 4102-1127-8062, therefore a reagent issue cannot be ruled out as a contributor to the event.No precision testing was performed on the vitros xt7600 system, therefore an analyzer issue cannot be ruled out as a contributor to the event.Repeat results that were within expectation for all samples were obtained on the same reagent cartridges as the initial results.This indicates that the issue is not likely related to the vitros k+ lot 4102-1127-8062 reagent cartridge in use.However, an individual slide related issue cannot be ruled out as a contributor to the event.Pre-analytical sample processing could not be ruled out as a contributing factor as it is unknown if the customer was following the sample collection device manufacturer's recommended centrifugation protocol.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros k+ lot 4102-1127-8062.

• Brand Name: VITROS CHEMISTRY PRODUCTS K+ SLIDES
• Common Device Name: 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18921206
• Report Number: 1319809-2024-00033
• Device Sequence Number: 6248498
• Product Code: CEM
• UDI-Device Identifier: 10758750010233
• UDI-Public: 10758750010233
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/15/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2024
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-1127-8062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown