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	12/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer obtained a lower than expected myoglobin (myo) result from a previously run proficiency fluid processed using vitros myo reagent lot 1720 on a vitros 5600 integrated system.Proficiency myo = 61.2 ng/ml versus originally reported myo = 101 ng/ml biased results of the direction and magnitude observed could lead to inappropriate physician action if undetected.The low vitros myoglobin result 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 inc.Complaint number (b)(4).
Additional Manufacturer Narrative
The investigation determined that a lower than expected myoglobin (myo) result was obtained from a previously run proficiency fluid processed using vitros myo reagent lot 1720 on a vitros 5600 integrated system.The assignable cause was not determined.The proficiency sample had been stored in the freezer.The vitros myoglobin instructions for use indicates samples are stable for < or = 4 weeks when stored frozen.It is possible that the low proficiency result was due pre-analytical sample handling specific to storage of the sample beyond what is recommended in the vitros myoglobin instructions for use but this was not confirmed.There was no further investigation performed for this proficiency sample.There was no evidence of an instrument malfunction.However, diagnostic precision testing was not conducted on the instrument around the time of the event.Therefore, an instrument issue cannot be completely ruled out as a contributor to the event.The non-vitros qc results on the day of the event were lower than expected and a vitros myoglobin lot 1720 issue could not be ruled out as a potential contributor to the event.

• 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: 16451960
• Report Number: 3007111389-2023-00031
• Device Sequence Number: 5530958
• Product Code: DDR
• UDI-Device Identifier: 10758750001019
• UDI-Public: 10758750001019
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/27/2023

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: 06/04/2021
• Device Model Number: 6801042
• Device Catalogue Number: 6801042
• Device Lot Number: 1720
• Was Device Available for Evaluation?: Yes
• 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: 12/06/2020
• Initial Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2020
• 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
• Patient Ethnicity: Non Hispanic