MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTICS PRODUCTS B-HCG II CALIBRATORS; IN VITRO DIAGNOSTICS

Catalog Number	6802221
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a higher-than-expected vitros b-hcg ii result was obtained from a single level of non-vitros biorad liquichek immunoassay plus control (lot 85360) when tested using vitros b-hcg ii lot 4280 on a vitros 5600 integrated system.Biorad lot 85361 result of 11.091 miu/ml versus the expected result of 5.908 miu/ml biased results of the magnitude and direction observed may lead to inappropriate physician action if the results were to recur undetected.The higher-than-expected vitros b-hcg ii result was obtained from a non-patient quality control fluid; however, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There were no allegations 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 (b)(4).
Additional Manufacturer Narrative
The investigation determined that a higher than expected vitros b-hcg ii result was obtained from a single level of non-vitros biorad liquichek immunoassay plus control (lot 85360) when tested using vitros b-hcg ii lot 4280 on a vitros 5600 integrated system.The cause of the event was a suboptimal calibration performed on 10 december 2024.The customer indicated that the cause of the suboptimal calibration was improper calibrator fluid handling, although the specific details were not provided.The customer performed a recalibration of vitros b-hcg ii lot 4280 using a new set of calibrators and the calibration responses were close to the fitted calibration parameters.In addition, biorad qc results following recalibration were accurate and precise, further demonstrating that recalibration using fresh calibrator fluid resolved the higher than expected vitros b-hcg results.A review of historical vitros b-hcg ii lot 4280 results from biorad qc indicated acceptable performance and ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros b-hcg reagent lot 4280.

• Brand Name: VITROS IMMUNODIAGNOSTICS PRODUCTS B-HCG II CALIBRATORS
• 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 21093743
• Report Number: 3007111389-2025-00002
• Device Sequence Number: 8934572
• Product Code: JIT
• UDI-Device Identifier: 10758750002337
• UDI-Public: (01)10758750002337(17)250609(11)240628(10)4280
• 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): 01/07/2025

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: 06/09/2025
• Device Catalogue Number: 6802221
• Device Lot Number: 4280
• 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: 12/10/2024
• Initial Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2024
• 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