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

Catalog Number	8157596
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected vitros potassium (k+) result was obtained from a single patient sample tested on a vitros xt 7600 integrated system.Patient sample k+ result of >14 mmol/l vs.The repeat result of 2.9 mmol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros k+ result was not reported outside of the laboratory and 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 (b)(4).
Additional Manufacturer Narrative
The investigation determined that a higher than expected vitros potassium (k+) result was obtained from a single patient sample tested on a vitros xt 7600 integrated system.The assignable cause of the event could not be determined.Improper pre-analytical sample processing could not be ruled out as a contributing factor.The customer was not following the sample collection device manufacture¿s recommendation for sample centrifugation and cellular debris, due to poor sample preparation, was potentially present in the affected sample, although this could not be confirmed.In addition, vitros na+ and k+ within-run precision testing performed was within acceptable guidelines, indicating the vitros na+ and k+ assays were performing as intended on the vitros xt7600 integrated system suggesting an instrument issue was not likely a contributing factor.However, the vitros na+ within-run precision test was not performed according to the guidelines required to completely assess the performance of the vitros xt7600 integrated system, therefore, an instrument related performance issue cannot be completely ruled out as contributing to the event.Finally, historical vitros k+ quality control results obtained from vitros k+ slide lot 4102-1116-5144 were acceptable, indicating the slide lot was performing as intended prior to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros k+ slide lot 4102-1116-5144.

• 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18521823
• Report Number: 0001319809-2024-00003
• Device Sequence Number: 6676474
• Product Code: CEM
• UDI-Device Identifier: 10758750010233
• UDI-Public: 10758750010233
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/16/2024

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: 03/01/2025
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-1116-5144
• 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: 12/25/2023
• Initial Report FDA Received Date: 01/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown