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	07/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that lower than expected results were obtained from two different levels of vitros therapeutic drug monitoring performance verifier (tdm pv) fluids and two different patient samples using the vitros valproic acid (valp) assay and one level of vitros tdm pv fluid and one different patient sample using the vitros vancomycin (vanc) assay.The affected samples were tested using vitros valp reagent lot 2511-32-1564 and vitros vanc lot 2514-54-1972 which were processed on a vitros xt 7600 integrated system.The assignable cause of the lower than expected results for each assay was a reagent pack related issue.The affected vitros valp results were isolated to a single reagent pack, pack id 339, and the affected vitros vanc results were isolated to a single reagent pack, pack id 9851.The cause of the issue with the affected reagent packs is unknown, as both reagent packs were discarded by the customer and no further investigation was possible.With the exception of the single affected vitros valp and vanc reagent packs, there was no indication that vitros valp reagent lot 2511-32-1564 or vitros vanc reagent lot 2514-54-1972 was not performing as intended, based on historical quality control results.Acceptable results were obtained from the same vitros tdm pv fluids using the vitros acet, crbm, phyt and dgxn assays, indicating there was not a performance issue associated with the vitros tdm pv fluids in use.There is no indication the vitros xt 7600 integrated system malfunctioned as acceptable vitros valp and vanc performance was obtained using alternate reagent packs of the same lot numbers without performing any actions to optimize instrument performance.This indicates the vitros xt 7600 integrated system did not likely contribute to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected results were obtained from two different levels of vitros therapeutic drug monitoring performance verifier (tdm pv) fluids and two different patient samples using the vitros valproic acid (valp) assay and one level of vitros tdm pv fluid and one different patient sample using the vitros vancomycin (vanc) assay.The affected samples were tested using vitros valp reagent lot 2511-32-1564 and vitros vanc lot 2514-54-1972 which were processed on a vitros xt7600 integrated system.Vitros valp reagent lot 2511-32-1564: vitros tdm pv i lot y1734 result of <10 ug/ml vs.The expected result of 27.0 ug/ml vitros tdm pv ii lot a1735 result of 12.2 ug/ml vs.The expected result of 70.0 ug/ml patient 1 sample vitros valp result of <10 ug/ml vs.The expected result of 99.9 ug/ml patient 2 sample vitros valp result of <10 ug/ml vs.The expected result of 69.0 ug/ml vitros vanc reagent lot 2514-54-1972: vitros tdm pv ii lot a1735 result of <5 ug/ml vs.The expected result of 21.8 ug/ml patient 4 sample vitros vanc result of <5 ug/ml vs.The expected result of 20.1 ug/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.None of the lower than expected vitros valp or vitros vanc patient sample results were reported outside of the laboratory.There was no allegation of patient harm as a result of this event.This report is number two 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 607101.

• 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: 20066715
• Report Number: 1319808-2024-00024
• Device Sequence Number: 8318030
• 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: BE
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 08/26/2024

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: 07/30/2024
• Initial Report FDA Received Date: 08/26/2024
• 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