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

Catalog Number	8001133
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported lower than expected vitros ckmb results were obtained from four different correlation patient samples using vitros ckmb slide lot 4917-0268-4441 on a vitros 4600 chemistry system, when compared to results obtained using an alternate vitros ckmb slide lot.The assignable cause of the event is unknown.A vitros ckmb slide lot 4917-0268-4441 performance issue did not likely contribute to the event as historic quality control results were acceptable.In addition, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros ckmb slide lot 4917-0268-4441.No diagnostic within-run precision testing was performed to assess the performance of the vitros 4600 chemistry system, however, since quality control results were acceptable using two different vitros ckmb reagent lots, it is unlikely the vitros 4600 chemistry system contributed to the event.It is unknown if improper pre-analytical sample processing contributed to the event.However, the samples were tested concurrently with both slide lots for both test events.Therefore, improper pre-analytical sample handling did not likely contribute to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros ckmb results were obtained from four different correlation patient samples using vitros ckmb slide lot 4917-0268-4441 on a vitros 4600 chemistry system, when compared to results obtained using an alternate vitros ckmb slide lot.Correlation patient sample 2 result of 16, 14 and 15 and u/l vs.The expected result of 31 u/l correlation patient sample 3 results of 14 and 11 and 11 u/l vs.The expected result of 30 u/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The lower-than-expected vitros ckmb results were obtained during a patient sample correlation and were not reported from the laboratory.There was no allegation of patient harm as a result of this event.This report is number two of six mdrs for this event.Six 3500a forms are being submitted for this event as six devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CKMB 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: 20255979
• Report Number: 1319809-2024-00075
• Device Sequence Number: 15389077
• Product Code: JHS
• UDI-Device Identifier: 10758750004201
• UDI-Public: (01)10758750004201(17)260101(11)240716(10)491702684441
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 09/18/2024

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: 01/01/2026
• Device Catalogue Number: 8001133
• Device Lot Number: 4917-0268-4441
• 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: 08/23/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2024
• 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