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

Catalog Number 6842781

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 10/24/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a discordant, non-reactive vitros hiv combo (hivc) result was obtained from a single patient sample when tested using vitros immunodiagnostic products hiv combo reagent lot#: 0530 on a vitros 3600 immunodiagnostic system.The result was considered discordant when compared to reproducible, reactive results obtained from the same sample using vitros hivc reagent lot#: 0520 tested on the same vitros 3600 immunodiagnostic system.A definitive cause of the discordant, non-reactive vitros hivc lot#: 0530 result was not determined with the limited information provided by the customer.A vitros hivc lot 0530 issue cannot be ruled out as a contributor to the event as no qc results were provided when requested to verify reagent performance.Additionally, the non-reactive vitros hivc lot#: 0530 result was discordant compared to reproducible, reactive vitros hivc testing from lot#: 0520, suggesting a possible issue with vitros hivc lot#: 0530.However, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros hivc lot#: 0530.An instrument issue cannot be ruled out as a contributor to the event as no diagnostic precision testing was conducted around the time of the event to verify instrument performance when requested.It is possible a sample interferent contributed to the non-reactive vitros hivc result for the patient, however, this could not be confirmed as no testing to rule out a possible sample interferent was conducted when requested.In addition, pre-analytical sample processing could not be ruled out as a contributing factor as it was not possible to determine whether the customer was following the sample collection device manufacturer¿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 sample when initially tested, although this could not be confirmed.The initial (b)(6) vitros hivc result was obtained on (b)(6) 2020.The reproducible (b)(6) vitros hivc results were obtained on (b)(6) 2020.No information was provided in regards to the handling and storage of the patient sample between the testing events.Therefore, the handling and storage of the patient sample between testing events cannot be ruled out as a contributor to the event.Insufficient information was provided by the customer to definitively establish what the true result for the sample is.However, ortho has decided to conservatively report the event as a false negative result.

Event Description

A customer reported a discordant, non-reactive vitros hiv combo (hivc) result obtained from a single patient sample tested using vitros immunodiagnostic products hiv combo reagent on a vitros 3600 immunodiagnostic system.The result was considered discordant when compared to reproducible, reactive results obtained from the same sample using an alternate lot of vitros hivc reagent tested on the same vitros 3600 immunodiagnostic system.Patient sample vitros hivc lot 0530 result of (b)(6).Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The discordant, non-reactive vitros hivc result was not reported from the laboratory.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.Complaint number: (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS HIV COMBO 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: joseph falvo ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10891075
• MDR Text Key: 218985829
• Report Number: 3007111389-2020-00188
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2020

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: 06/07/2021
• Device Catalogue Number: 6842781
• Device Lot Number: 0530
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1