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

Model Number	6801042
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted ortho to report a lower than expected myoglobin result obtained from a previously reported cap proficiency fluid processed using vitros myoglobin reagent lot 1600 on a vitros 5600 integrated system.Cap proficiency sample b = 55 ng/ml versus expected 65 ng/ml biased results of the direction and magnitude observed could lead to inappropriate physician action they were to occur undetected.The lower than expected vitros myoglobin result was obtained from a previously reported cap proficiency sample and was not reported outside of the laboratory.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics (ortho) complaint number (b)(4)/ reportabiity assessment (b)(4).
Additional Manufacturer Narrative
The investigation determined that a lower than expected myoglobin result was obtained from a previously reported cap proficiency fluid processed using vitros myoglobin reagent lot 1600 on a vitros 5600 integrated system.The assignable cause was not determined.The low myoglobin proficiency result was obtained while investigating an issue with biorad quality control performance.The customer considered the myoglobin proficiency result to be acceptable when compared to the reported result and therefore, no further investigation was performed to determine the cause of the low proficiency result.A vitros myoglobin lot 1600 reagent issue could not be completely ruled out as potential contributing factor as the customer was investigating a myoglobin qc issue with their biorad controls.However, a complaint review did not indicate an issue with myoglobin lot 1600.Ongoing tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros myoglobin reagent lot 1600.There was no evidence of an instrument malfunction.However, as no diagnostic precision testing was conducted to verify instrument performance, an instrument issue cannot be completely ruled out as a contributor to the event.Finally, a sample related issue could not be ruled out as potential contributing factor to the event as the lower than expected result was obtained from an aged proficiency sample that was stored frozen for approximately 4 months.Per the vitros myoglobin instructions for use, samples are stable for < or = 4 weeks when frozen.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS MYOGLOBIN 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: 16467016
• Report Number: 3007111389-2023-00037
• Device Sequence Number: 7774854
• Product Code: DDR
• UDI-Device Identifier: 10758750001019
• UDI-Public: 10758750001019
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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

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: 01/13/2021
• Device Model Number: 6801042
• Device Catalogue Number: 6801042
• Device Lot Number: 1600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2020
• 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