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

Catalog Number	8157596
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected vitros potassium (k+) results were obtained from a single level of vitros performance verifier (pv) ii, lot p9966, tested on a vitros 4600 chemistry system.The assignable cause of the event is unknown.Historical qc for vitros k+ lot 4102-1101-0943 leading up to the lower than expected results was acceptable, showing that this lot was performing within expectation.Additionally, repeat results from samples from a previous college of american pathologists (cap) survey were acceptable when run using vitros k+ lot 4102-1101-0943, further indicating that the reagent lot was functioning as expected and did not likely contribute to the event.Diagnostic precision testing performed using vitros na+, vitros k+ and vitros alkp was within ortho acceptable guidelines, indicating that the analyzer was operating as expected at the time of the precision testing.However, as no precision testing was performed at the time of the event, a transient instrument issue cannot be ruled out as a potential contributor to the event.Continual tracking and trending does not indicate a systemic issue with vitros k+ lot 4102-1101-0943.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros potassium (k+) results were obtained from a single level of vitros performance verifier (pv) ii, lot p9966, tested on a vitros 4600 chemistry system.Vitros k+ pvii lot p9966 results of 3.46 and 3.74 mmol/l versus the baseline mean result of 5.707 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower than expected results were obtained from a non-patient quality control fluid.There was no allegation of patient harm as a result of this event.This report is number two of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment b4.

• 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: 17736821
• Report Number: 0001319809-2023-00094
• Device Sequence Number: 15120503
• Product Code: CEM
• UDI-Device Identifier: 10758750010233
• UDI-Public: 10758750010233
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 09/12/2023

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: 10/01/2024
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-1101-0943
• 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: 08/17/2023
• Initial Report FDA Received Date: 09/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2023
• 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