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	05/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that lower than expected myoglobin results were obtained from a non-vitros mas control lot cx023630 processed using vitros myo reagent lot 1940 on a vitros xt7600 integrated system.The assignable cause was not determined.The qc results were identified while reviewing historical quality control performance for another issue.There was no investigation performed to determine the cause of the low results.Therefore, a reagent issue, an instrument malfunction and a qc sample related issue could not be ruled out as potential contributing factors to the event.
Event or Problem Description
The customer reported lower than expected myoglobin results were obtained from a non-vitros mas control lot cx023630 processed using vitros myo reagent lot 1940 on a vitros xt7600 integrated system.Mas level 1 = 54.969, 56.991 ng/ml versus package insert mean = 67.0 ng/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The unexpected vitros myoglobin results were generated from non-patient fluids, however the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• 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: 16449288
• Report Number: 3007111389-2023-00033
• Device Sequence Number: 12223356
• Product Code: DDR
• UDI-Device Identifier: 10758750001019
• UDI-Public: 10758750001019
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: 11/05/2022
• Device Model Number: 6801042
• Device Catalogue Number: 6801042
• Device Lot Number: 1940
• 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: 06/13/2022
• Initial Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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