MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1; IN-VITRO DIAGNOSTICS

Catalog Number	1882208
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation determined that higher than expected vitros creatinine (crea) results were obtained from vitros performance verifier (pv) i using vitros crea slide lot 1506-3546-8441 tested on a vitros xt 3400 chemistry system.The assignable cause of the event was a suboptimal calibration event.The parameters of the calibration event were determined to be suboptimal.The cause of the suboptimal calibration event remains unknown due to the limited information provided by the customer.No information was provided by the customer regarding calibrator fluid handling and storage, and therefore it is unknown if the customer is following manufacturer recommendations for this material.It is possible that improper calibrator fluid handling could have contributed to this suboptimal calibration event.Acceptable vitros crea qc performance was obtained using an alternate set of calibration parameters obtained from the same vitros crea reagent gen 06 lot as well as from an alternate vitros crea gen 10 reagent.In addition, quality control results processed on the same vitros analyzers using the same vitros pv lots were acceptable on an alternate vitros crea slide lot 1510-3543-6865.This indicated neither vitros crea slide lot 1506-3546-8441, vitros pv fluids, nor the vitros xt3400 chemistry system likely contributed to the event.
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report higher than expected vitros creatinine (crea) results were obtained from vitros performance verifier (pv) i using vitros crea slide lot 1506-3546-8441 tested on a vitros xt 3400 chemistry system.Vitros pv i lot q1174 vitros crea result of 1.52, 1.53, and 1.53 mg/dl vs.The vitros range of mean midpoint value of 1.03 mg/dl vitros pv i lot v1665 vitros crea result of 1.51 and 1.55 mg/dl vs.The expected vitros range of mean midpoint value of 0.92 mg/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher than expected vitros crea results were obtained from a non-patient quality control fluid, however, the investigation could not rule out that patient samples were not or 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 (ortho) complaint number (b)(4) and reportability assessment 607072.

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
• 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: 20036337
• Report Number: 1319808-2024-00021
• Device Sequence Number: 12368140
• Product Code: JIX
• UDI-Device Identifier: 10758750000166
• UDI-Public: (01)10758750000166(17)250601(11)230601(10)0173
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 08/21/2024

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: 06/01/2025
• Device Catalogue Number: 1882208
• Device Lot Number: 0173
• 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: 07/25/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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