MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL 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	05/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that higher than expected vitros bhcg results were obtained from a single level of non-vitros biorad liquichek immunoassay plus controls, lot 1003900, when using vitros bhcg reagent lot 4600, on a vitros xt7600 system.Biorad l1 vitros bhcg results of 7.79, 7.54, 7.88, 8.12 and 7.95 miu/ml vs.The biorad lot 1003900 package insert target of 4.59 miu/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 higher-than-expected vitros bhcg results were obtained from non-patient quality control fluids.The customer did not process any patient samples, since the biorad control results were outside the pi ranges for those fluids.There was no allegation of harm.This report is number one of three 3500a forms are being submitted for this event as three devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and reportability assessment (b)(4).
Additional Manufacturer Narrative
The customer reported that higher than expected vitros bhcg results were obtained from a single level of non-vitros biorad liquichek immunoassay plus controls, lot 1003900, when using vitros beta human chorionic gonadotropin (bhcg) reagent lot 4600, on a vitros xt7600 system.The investigation concluded the assignable cause for the elevated vitros bhcg control results was suboptimal calibrations caused by user error.The customer had improperly reconstituted the vitros bhcg lot 4600 calibrator fluids with 2.0 ml of fs diluent.The vitros bhcg reagent and calibrators instructions for use (ifu) specifies the vitros bhcg calibrators are supplied freeze-dried and are reconstituted with 1.0 ml of distilled water.The customer is using incorrect calibrator reconstitution by using an incorrect volume of an incorrect diluent to reconstitute the affected calibrators.The investigation could not rule out that patient samples would not be affected if the event recurred undetected.Acceptable performance was obtained using a calibration generated from properly reconstituted vitros bhcg calibrators.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL 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: 22338683
• Report Number: 3007111389-2025-00075
• Device Sequence Number: 9060348
• Product Code: JIT
• UDI-Device Identifier: 10758750002337
• UDI-Public: (01)10758750002337(17)260329(11)250411(10)4600
• 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): 06/26/2025

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: 03/29/2026
• Device Catalogue Number: 6802221
• Device Lot Number: 4600
• 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: Not provided
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• 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