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

Model Number	6801709
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation has determined that lower than expected vitros vancomycin (vanc) results were obtained from two different levels of non-vitros mas lot: cha24080 control fluids and the results obtained from the level 2 control met potential health and safety criteria.The results were obtained on a vitros xt7600 integrated system.The most likely assignable cause of the event was the vitros vanc reagent packs in use at the time of the event.The customer stated that during the timeframe of this event, the refrigerator where the vitros microtip reagents were stored, including the vitros vanc reagent, malfunctioned, and some reagent packs were frozen.It is possible the affected reagent packs were frozen.Per the vitros vanc instructions for use, only refrigerated storage is specified as acceptable.A systemic performance issue vitros vanc lot: 2514-49-9851 did not likely contribute to the event as acceptable vitros vanc results were obtained prior to the event using alternate reagent packs of the same reagent lot.In addition, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros vanc lot: 2514-49-9851.A performance issue with the vitros xt7600 integrated system did not likely contribute to the event as diagnostic within-run precision testing was performed and the results indicated the vitros xt7600 integrated system was performing as intended.
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 two different levels of non-vitros mas lot: cha24080 control fluids and the results obtained from the level 2 control met potential health and safety criteria.The results were obtained on a vitros xt7600 integrated system.Mas level 2 results of <5.0 ug/ml (x3) vs.The target value of 32.0 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 mdr¿s 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).

• 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 16225265
• Report Number: 0001319808-2023-00001
• Device Sequence Number: 6313098
• Product Code: LEH
• UDI-Device Identifier: 10758750006731
• UDI-Public: 10758750006731
• 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): 01/20/2023

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: 02/24/2023
• Device Model Number: 6801709
• Device Catalogue Number: 6801709
• Device Lot Number: 2514-49-9851
• 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: 12/26/2022
• Initial Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2022
• 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