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

Catalog Number 6802220

Device Problems High Test Results (2457); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/11/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a non-reproducible, discordant, higher than expected vitros hcg ii (b-hcg) result was obtained from a single patient sample when tested using vitros b-hcg lot 3390 on a vitros eci immunodiagnostic system.A definitive cause of the event was not established.A vitros b-hcg lot 3390 reagent issue cannot be ruled out as a contributor to the event.Quality control results leading up to the event indicate acceptable reagent performance when compared to the customers established baseline mean/ sd.However, the customer did not provide any manufacturer lot information, therefore peer mean/ sd and package insert mean/ sd information was unable to be retrieved for comparison to support acceptable performance.However, continual 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 3390.An instrument issue cannot be ruled out as a contributor to the event.An ortho field engineer performed service actions over several days at the customer site, which included preventative cleaning of the system and sample arm adjustments, replacing the well wash aspirate filter, replacing the well wash nozzle, servicing the signal reagent module, servicing the microwell incubator, and servicing the reagent supply.However, diagnostic precision testing was not conducted before or after the service actions, and no quality control data was provided following service.Therefore, an instrument issue cannot be completely confirmed or ruled out as a contributor to the event.In addition, pre-analytical sample processing could not be ruled out as a contributing factor as it is unknown if the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.As the repeat vitros b-hcg result (<2.39 miu/ml ) was different to the initial vitros b-hcg result (19.87 miu/ml) for patient 1, patient sample mix up cannot be ruled out as a contributor to the event.Email address for contact office is (b)(4).

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report a non-reproducible, discordant, higher than expected vitros hcg ii (b-hcg) result was obtained from a single patient sample when tested using vitros b-hcg lot 3390 on a vitros eci immunodiagnostic system.Patient 1 vitros b-hcg result of 19.87 miu/ml versus the expected result of < 2.39 miu/ml 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.No treatment was altered, initiated or stopped based on the initially reported result.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 ivd (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B HCG II REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 15282131
• MDR Text Key: 304128086
• Report Number: 3007111389-2022-00082
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2022
• Device Catalogue Number: 6802220
• Device Lot Number: 3390
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: N/A.