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

Catalog Number	8058232
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
An investigation by ortho clinical diagnostics (ortho) determined higher than expected vitros ckmb results were obtained from two different patient correlation samples using vitros ckmb slide lot: 4915-0261-6318 when compared to vitros ckmb results obtained from the same samples using vitros ckmb slide lot: 4917-0264-0605.The correlation samples were tested on the same vitros 4600 chemistry system.Correlation sample12 vitros ckmb slide lot: 4915-0261-6318 result of 18 u/l vs.The vitros ckmb slide lot: 4917-0264-0605 result of 4 u/l correlation sample14 vitros ckmb slide lot: 4915-0261-6318 result of 35 u/l vs.The vitros ckmb slide lot: 4917-0264-0605 result of <14 u/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 higher-than-expected vitros ckmb results were obtained as part of an ortho investigation and were not reported.There was no allegation of patient harm as a result of this event.This report is number two of two mdrs 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).
Additional Manufacturer Narrative
An investigation by ortho clinical diagnostics (ortho) determined higher than expected vitros ckmb results were obtained from two different patient correlation samples using vitros ckmb slide lot: 4915-0261-6318 when compared to vitros ckmb results obtained from the same samples using vitros ckmb slide lot: 4917-0264-0605.The correlation samples were tested on the same vitros 4600 chemistry system.The most likely assignable cause of the event is a known limitation of the vitros ckmb slide assay manufactured from coating 0261.Correlation samples 12 and 14 had elevated vitros ck results when compared to the vitros reference interval for males of 55-170 u/l.Correlation sample 12 had a vitros ck result of 823 u/l and correlation sample 14 had a vitros ck result of 4588 u/l.Ortho initially opened an investigation (trackwise (b)(4) on 05 november 2020 for this issue.The investigation determined that field action was required and this was classified as a class ii recall by the us fda on 22 december 2020 (fda reference: z-0770-2021, res 87028).On 10 october 2023, an extension of the december 2020 class ii recall was opened (windchill pqi0001700) and further investigation determined the potential for falsely elevated creatine kinase mb results when using lots of vitros chemistry products ckmb slides manufactured from coating 0261.Per technical support communication cl2023-244 (october 2023), per the vitros ckmb slides instructions for use (ifu) "principals of the procedure" section, the spread layer of the ckmb slide contains goat antihuman ck-mm antibodies, which inhibit ck-mm (muscle) activity and ~50% of the ck-mb (heart) activity.The remaining ck activity represents 50% of the total ck-mb isoenzyme activity plus any ck-bb (which is relatively rare).Per the current vitros ckmb slides ifu "known interferences" section, a total ck activity greater than 1000 u/l may result in falsely elevated ck-mb results.It is limited at 1000 u/l by design, which is due to the level of goat antihuman ck-mm antibodies added during manufacturing.Samples with total ck >1000 u/l should be diluted prior to analysis.Therefore, ck will not typically impact vitros ckmb results below the ck result of 1000 u/l.Ortho clinical diagnostics (quidelortho) has confirmed the issue and determined that lots manufactured from coating 0261 of vitros ckmb slides do not adequately inhibit ck-mm up to a total ck >1000 u/l (as stated in the ifu).Based on vitros ckmb quality control results processed on the date of the event, there was no indication that vitros ckmb slide lot: 4915-0261-6318 had a systemic performance issue that would have contributed to the event.Since the event occurred in may 2024, it is not possible to assess the performance of vitros j46001070 at the time of the event.No diagnostic within-run precision testing was performed at the time of the event, therefore, an unknown performance issue with j460010170 cannot be completely ruled out as contributing to the event.

• 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: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 23357690
• Report Number: 1319809-2025-00084
• Device Sequence Number: 21050570
• Product Code: JHS
• UDI-Device Identifier: 10758750004294
• UDI-Public: (01)10758750004294(17)250401(11)230401(10)491502616318
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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: 04/01/2025
• Device Catalogue Number: 8058232
• Device Lot Number: 4915-0261-6318
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2023
• 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