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	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report lower than expected b-hcg ii results were obtained when two api proficiency samples were tested using vitros b-hcg lot 3580 on a vitros 5600 integrated system.Api first (remedial) survey, sample 1, vitros b-hcg ii result of <2.39 miu/ml versus the midpoint of the api range of 6.2 miu/ml (api range: 0.0 ¿ 12.4 miu/ml) api first (remedial) survey, sample 5, vitros b-hcg ii result of <2.39 miu/ml versus the midpoint of the api range of 6.2 miu/ml (api range: 0.0 ¿ 12.4 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 lower than expected vitros b-hcg results of <2.39 miu/ml were obtained from non-patient samples.Ortho has not been made aware of any allegation of patient harm as a result of this 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 lower than expected b-hcg ii results were obtained when two api proficiency samples were tested using vitros b-hcg lot 3580 on a vitros 5600 integrated system.A definitive cause of the event was not established.A vitros b-hcg ii lot 3580 reagent issue cannot be ruled out as a contributor to the event as results identified as meeting potential health and safety criteria were isolated to lot 3580.However, historical results for qcs within the range for api sample 1 and api sample 5 indicated acceptable vitros b-hcg ii 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 3580.There was no evidence of an instrument malfunction, however, as no diagnostic precision testing was conducted to verify the performance of the vitros 5600 integrated system, an instrument issue cannot be completely ruled out as a contributor to the event.No information was provided in relation to the preparation and handling of the api samples.It is possible improper preparation and handling of the api proficiency samples contributed to this event; however, this could not be confirmed.Furthermore, issues regarding the stability of the api samples cannot be ruled out as a contributor to the event, as the results that were identified as meeting potential health and safety criteria (api sample 1 and api sample 5) were from the first api survey which was classed as a 'remedial' survey.It is possible the proficiency samples for the first (remedial) survey were sent to participants early in 2023 and not tested by the customer until (b)(6) 2023.The vitros b-hcg ii ifu states specimens may be stored for up to 5 days at 2¿8 °c (36¿46 °f) or 4 weeks at -20 °c (-4 °f).

• 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 17396852
• Report Number: 3007111389-2023-00122
• Device Sequence Number: 18035421
• Product Code: DHA
• UDI-Device Identifier: 10758750002320
• UDI-Public: 10758750002320
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 07/26/2023

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: 07/06/2023
• Device Catalogue Number: 6802220
• Device Lot Number: 3580
• 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: 06/28/2023
• Initial Report FDA Received Date: 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2022
• 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