MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS CKMB REAGENT PACK; IN-VITRO DIAGNOSTICS

Model Number	1896836
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that a higher than expected vitros ckmb result was obtained from a single patient sample tested on a vitros 5600 system when compared to a non-vitros abbott ckmb result.The assignable cause of the event is unknown with the information provided.The customer did not perform any additional testing results using appropriate blocking tubes, therefore, the presence heterophilic antibody sample interferent causing the higher than expected vitros ckmb result cannot be completely ruled out as contributing to the event.The customer does not test quality control fluids to assess the performance of the vitros ckmb assay.Therefore, a vitros ckmb reagent performance issue cannot be ruled out as contributing to the event.However, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros ckmb reagent lot 3270.The customer made no allegation that there was issue with the performance of the vitros 5600 integrated system, however, since no diagnostic within-run precision testing was performed within the timeframe of the event.Therefore, an instrument related performance issue cannot be ruled out as contributing to the event.In addition, pre-analytical sample processing could not be ruled out as a contributing factor, as it was established the customer was not following the sample collection device manufacture¿s recommendation for sample centrifugation.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 higher than expected vitros ckmb result was obtained from a single patient sample tested on a vitros 5600 system when compared to a non-vitros abbott ckmb result.Patient sample result of 170 ng/ml vs.The expected result of 0.60 ng/ml.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 ckmb result was not reported from 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).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS CKMB REAGENT PACK
• 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; felindre meadows; pencoed; bridgend CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 16548203
• Report Number: 3007111389-2023-00041
• Device Sequence Number: 17708361
• Product Code: JHX
• UDI-Device Identifier: 10758750000203
• UDI-Public: 10758750000203
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2023

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: 04/17/2023
• Device Model Number: 1896836
• Device Catalogue Number: 1896836
• Device Lot Number: 3270
• 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: 02/15/2023
• Initial Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2022
• 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