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

Catalog Number 6842781

Device Problem False Negative Result (1225)

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

Event Date 08/10/2023

Event Type  malfunction  

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report reproducible, discordant false negative vitros hiv combo (hivc) results were obtained from a single patient sample when tested on a vitros 3600 immunodiagnostic system.The results were considered discordant when compared to reactive results obtained from the same patient sample when tested using non-vitros methods.Patient sample 1 results of 0.37 and 0.40 s/c (negative) versus the expected result of reactive biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, negative vitros hivc results were not reported outside the laboratory and there was 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 603042.

Manufacturer Narrative

The investigation has determined that reproducible, discordant false negative vitros hiv combo (hivc) results were obtained from a single patient sample when tested on a vitros 3600 immunodiagnostic system.The results were considered discordant when compared to reactive results obtained from the same patient sample when tested using non-vitros methods.A definitive assignable cause for the discordant negative results could not be determined.Based on historical quality control results, a vitros hivc lot 0920 performance issue is not a likely contributor to the event.A within run precision test performed by the customer was within ortho guidelines indicating that the vitros 3600 system is performing as expected and therefore an instrument issue is not a likely contributor to the event.In addition, it is unknown if the customer is following the sample collection device manufacturer¿s recommended centrifugation protocol; therefore, pre-analytical sample processing cannot be ruled out as a contributing factor.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.Furthermore, the presence of a sample specific interferent cannot be completely ruled out as contributing to the event.Testing using heterophilic and non-specific antibody blocking tubes did not produce a definitive difference in result, but this does not preclude the presence of another sample specific interferent as contributing to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros hivc lot 0920.

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO 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: 17728098
• MDR Text Key: 323154809
• Report Number: 3007111389-2023-00156
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 10758750031580
• UDI-Public: 10758750031580
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: 09/11/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2024
• Device Catalogue Number: 6842781
• Device Lot Number: 0920
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2023
• Initial Date FDA Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1