MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B HCG II REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number	6802220
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a higher than expected b-hcg result was obtained from a single patient sample when using vitros immunodiagnostics product b-hcg ii reagent on three (3) different vitros xt 7600 integrated systems.Patient 1 vitros b-hcg ii result of 72.60 miu/l vs.The expected vitros b-hcg ii result of <2.39 miu/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros b-hcg result was not reported from the laboratory.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) , and reportability assessment (b)(4).
Additional Manufacturer Narrative
The investigation determined that a higher than expected b-hcg result was obtained from a single patient sample when using vitros immunodiagnostics product b-hcg ii reagent on three (3) different vitros xt 7600 integrated systems.A definitive cause for the higher than expected patient sample result could not be determined.Historical quality control data indicates some within-lab vitros b-hcg imprecision for the biorad control, however, the imprecision was slight when compared to the magnitude of bias associated with the higher than expected vitros b-hcg patient result.Therefore, a vitros b-hcg reagent issue is an unlikely contributor to this event but cannot be completely ruled out as a contributing factor.The ortho tsc requested the customer to perform diagnostic within run precision testing to verify the performance of the vitros xt 7600 integrated systems, however, the customer has not carried out any precision testing on the instruments.Additionally, no precision testing was carried out at the time of the events, therefore, an instrument issue cannot be ruled out as contributing to these events.Pre-analytical sample handling could not be ruled out as a potential contributing factor as the tsc was unable to determine if the customer was following the sample collection device manufacture's recommendation for sample centrifugation.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Additionally, a possible patient sample mix-up contributed to the event.The customer indicated that it was possible that the initial sample tube was mislabeled, although this could not be confirmed.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros b-hcg lot 3930.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B HCG II REAGENT PACK
• 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: 18857481
• Report Number: 3007111389-2024-00052
• Device Sequence Number: 18202713
• Product Code: DHA
• UDI-Device Identifier: 10758750002320
• UDI-Public: 10758750002320
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2024

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: 08/08/2024
• Device Catalogue Number: 6802220
• Device Lot Number: 3930
• 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: 02/09/2024
• Initial Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown