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

Model Number	6802220
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2023
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 vitros total b-hcg ii (bhcg) results were obtained from vitros reproductive endocrinology (re) quality controls using vitros immunodiagnostics products total bhcg ii reagent lot 3580 in combination with a vitros eci immunodiagnostic system.Vitros re lot 0830 level 1 results of 3.48, 3.42, 3.44, 3.5, 3.67, 3.61, 3.46, 3.48, 3.56, 3.57, 3.52 and 3.54 iu/l vs an expected result of 11.06 iu/l 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 bhcg results were from non-patient fluids.The customer did not give any indication that patient results had been affected.There is no 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 vitros total b-hcg ii (bhcg) results were obtained from vitros reproductive endocrinology quality controls using vitros immunodiagnostics products total bhcg ii reagent lot 3580 in combination with a vitros eci immunodiagnostic system.A definitive assignable cause of the event could not be determined.A possible cause for the initial lower than expected vitros bhcg qc fluid results is a suboptimal calibration.The parameters for the calibration used when obtaining the initial lower than expected results were atypical when compared to database values and the previous calibration.The cause of the suboptimal calibration is unknown.Based on historical quality control results from non-vitros biorad qc fluids, a vitros bhcg lot 3580 performance issue is not a likely contributor to the event.However, as vitros re results returned to expectations using an alternate lot of vitros bhcg reagent, an issue related to vitros bhcg lot 3580 cannot be ruled out as a contributing factor of the event.An instrument related issue is not likely a contributor of the event as vitros tsh within run precision results were within ortho acceptable guidelines.Additionally, the use of an alternate vitros bhcg reagent resolved the issue without any known actions being performed on the vitros eci system.A vitros re lot 0830 related issue cannot be ruled out as a contributor of the event as the issue was resolved using an alternate lot of re controls along with an alternate lot of vitros bhcg reagent.In addition, as the results for each level of vitros re controls lot 0830 were significantly lower than the pi means, an issue related to sample handling cannot be ruled out as a possible cause of the lower than expected results.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros bhcg reagent lot 3580 or vitros re controls lot 0830.

• 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: 16349311
• Report Number: 3007111389-2023-00015
• Device Sequence Number: 12471735
• Product Code: DHA
• UDI-Device Identifier: 10758750002320
• UDI-Public: 10758750002320
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (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): 02/09/2023

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 Model Number: 6802220
• 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: 01/14/2023
• Initial Report FDA Received Date: 02/10/2023
• 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