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	01/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has 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 4102-1126-7817 on a vitros xt 7600 integrated system.The investigation could not determine a definitive assignable cause of the event.A possible cause of the event is an instrument related issue.The pm evaporation caps of the vitros xt 7600 system had not been cleaned during the month of (b)(6) 2024 as required for monthly maintenance.The initial result was obtained from a different incubator slot on the vitros instrument than the repeat result and it's possible that one or both the evaporation caps were dirty.An ortho laboratory specialist cleaned the pm evaporation caps and processed post maintenance precision testing in which the results were within ortho acceptable guidelines.However, as no pre maintenance precision testing was performed and as the post maintenance precision testing was processed with an alternate lot of vitros k+ reagent, an instrument issue could not be confirmed nor ruled out as contributing factors of the event.Based on historical quality control results, a vitros k+ lot 4102-1126-7817 performance issue is not a likely contributor of the event.However, an individual slide related issue could not be entirely ruled out.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros k+ lot 4102-1126-7817 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.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.
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 4102-1126-7817 on a vitros xt 7600 integrated system.Patient sample result of >14.00 mmol/l vs the expected result of 2.87 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).

• 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: 18773020
• Report Number: 1319809-2024-00025
• Device Sequence Number: 17258870
• Product Code: CEM
• UDI-Device Identifier: 10758750010233
• UDI-Public: 10758750010233
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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): 02/23/2024

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: 06/01/2025
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-1126-7817
• 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: 01/30/2024
• Initial Report FDA Received Date: 02/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown