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

Catalog Number	6801709
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected vitros vancomycin (vanc) results were obtained from a single level of vitros therapeutic drug monitoring performance verifier (tdm pv) iii, lot b1736 and a single level of non-vitros biorad immunoassay plus control, lot 85360 tested on a vitros xt7600 integrated system.Vitros tdm pv iii lot b1736 results of <5.0 ug/ml (x3) vs.The baseline mean of 32.7 ug/ml biorad lot 85360 level 3 result of <5.0 ug/ml vs.The target value of 27.03 ug/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 lower than expected results were obtained from non-patient quality control fluids.The customer made no allegation that erroneous patient results had been reported from the laboratory.There was no allegation of patient harm.This report is number one 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) and reportability assessment 606631.
Additional Manufacturer Narrative
The investigation has determined that lower than expected vitros vancomycin (vanc) results were obtained from a single level of vitros therapeutic drug monitoring performance verifier (tdm pv) iii, lot b1736 and a single level of non-vitros biorad immunoassay plus control, lot 85360 tested on a vitros xt7600 integrated system.The assignable cause of the event could not be determined.Based on historical quality control results, a vitros vanc reagent lot 2514-54-1972 performance issue cannot be ruled out as a contributor of the event.The lower than expected results were isolated to two vitros vanc lot 2514-54-1972 reagent packs, therefore, a performance issue with the reagent packs in use cannot be ruled out as contributing to the event.However, both acceptable and unacceptable results were obtained from one of the two reagent packs, therefore, it cannot be confirmed the affected reagent packs were the assignable cause of the event.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros vanc reagent lot 2514-54-1972.Vitros vanc within-run precision testing indicated vitros vanc lot 2514-54-1972 was performing as intended on the vitros xt7600 integrated system and an instrument related performance issue did not likely contribute to the event.However, since no diagnostic within-run precision testing was performed to verify instrument performance, an instrument-related performance issue cannot be completely ruled out as contributing to the event.

• Brand Name: VITROS CHEMISTRY PRODUCTS VANC REAGENT
• 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.; 1000 lee road; rochester NY 14606
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 19722209
• Report Number: 1319808-2024-00018
• Device Sequence Number: 18211541
• Product Code: LEH
• UDI-Device Identifier: 10758750006731
• UDI-Public: (01)10758750006731(17)240813(11)230913(10)541972
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 07/09/2024

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: 08/13/2024
• Device Catalogue Number: 6801709
• Device Lot Number: 2514-54-1972
• 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: 06/13/2024
• Initial Report FDA Received Date: 07/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2023
• 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