MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK; IN-VITRO DIAGNOSTICS

Catalog Number 6801925

Device Problem False Positive Result (1227)

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

Event Date 12/11/2023

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, positive vitros anti-hbs (ahbs) results were obtained from a single patient sample when tested using two different lots of vitros ahbs reagent on two different vitros 3600 immunodiagnostic systems.The vitros results were considered discordant when compared to a non-vitros abbott ahbs negative result for the same patient sample.Patient 1, results of 25.7, 23.5 and 19.7 miu/ml (positive) vs expected results of negative biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The vitros ahbs results were reported from the laboratory.However, no treatment was initiated, altered, or stopped based on the reported results.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 numbers (b)(4) and reportability assessment (b)(4).

Manufacturer Narrative

The investigation determined that discordant, positive vitros anti-hbs (ahbs) results were obtained from a single patient sample when tested using two different lots of vitros ahbs reagent on two different vitros 3600 immunodiagnostic systems.The vitros results were considered discordant when compared to a non-vitros abbott ahbs negative result for the same patient sample.An assignable cause of the event could not be determined.Historical qc fluid performance indicates a vitros ahbs lot 5120 performance issue is not a likely contributor to the event.No precision testing was performed on the vitros 3600 immunodiagnostic systems at the time of the events and therefore, an instrument related issue cannot be entirely ruled out as a contributor of the events.However, historical vitros qc fluid results were precise, and no evidence of any instrument malfunction were reported, therefore, an instrument issue is an unlikely cause of the event.Pre-analytical sample processing could not be ruled out as a contributing factor, as it was determined that the customer was not following the sample collection device manufacture¿s recommendation for sample centrifugation.Therefore, improper pre-analytical sample handling could be a contributor to this event.As per the ortho medical safety officer, ¿when used in a panel, the result of the ahbs may be discordant with other results in the panel.A positive ahbs is not expected with a positive hbsag.However, there are rare cases when both coexist.Thus, when ahbs is used in a panel, the likelihood of inappropriate physician intervention based on an erroneous result is remote.In this case, discordance between the hbsag result and the ahbs must have aroused the physician's suspicion to request repeat testing, preventing an erroneous diagnosis of disease resolution.Therefore, the risk of short- or long-term patient injury in this case is unlikely.¿ continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ahbs reagent lot 5120.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, positive vitros anti-hbs (ahbs) results were obtained from a single patient sample when tested using two different lots of vitros ahbs reagent on two different vitros 3600 immunodiagnostic systems.The vitros results were considered discordant when compared to a non-vitros abbott ahbs negative result for the same patient sample.Vitros ahbs regent lot 5120 tested on (b)(6) patient 1 results of positive (25.7 and 23.5 miu/ml) vs expected results of negative.Vitros ahbs regent lot 5130 tested on (b)(6) patient 1 result of positive (19.7 miu/ml) vs expected results of negative biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The vitros ahbs results were reported from the laboratory.However, no treatment was initiated, altered, or stopped based on the reported results.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number one of two 3500a forms filed for this event, as two devices were affected.This report corresponds to ortho clinical diagnostics inc (ortho) complaint numbers (b)(4) and reportability assessment (b)(4).

Manufacturer Narrative

The investigation determined that discordant, positive vitros anti-hbs (ahbs) results were obtained from a single patient sample when tested using two different lots of vitros ahbs reagent on two different vitros 3600 immunodiagnostic systems.The vitros results were considered discordant when compared to a non-vitros abbott ahbs negative result for the same patient sample.An assignable cause of the event could not be determined.Historical qc fluid performance indicates a vitros ahbs lot 5120 and lot 5130 performance issue is not a likely contributor to the event.No precision testing was performed on the vitros 3600 immunodiagnostic systems at the time of the events and therefore, an instrument related issue cannot be entirely ruled out as a contributor of the events.However, historical vitros qc fluid results were precise, and no evidence of any instrument malfunction were reported, therefore, an instrument issue is an unlikely cause of the event.Pre-analytical sample processing could not be ruled out as a contributing factor, as it was determined that the customer was not following the sample collection device manufacture's recommendation for sample centrifugation.Therefore, improper pre-analytical sample handling could be a contributor to this event.As per the ortho medical safety officer, "when used in a panel, the result of the ahbs may be discordant with other results in the panel.A positive ahbs is not expected with a positive hbsag.However, there are rare cases when both coexist.Thus, when ahbs is used in a panel, the likelihood of inappropriate physician intervention based on an erroneous result is remote.In this case, discordance between the hbsag result and the ahbs must have aroused the physician's suspicion to request repeat testing, preventing an erroneous diagnosis of disease resolution.Therefore, the risk of short or long-term patient injury in this case is unlikely." continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ahbs reagent lots 5120 and 5130.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBS REAGENT PACK
• Type of Device: 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: 18524845
• MDR Text Key: 333016169
• Report Number: 3007111389-2024-00011
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 10758750001682
• UDI-Public: 10758750001682
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6801925
• Device Lot Number: 5120
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1