MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR HIV AG/AB COMBO (CHIV); TEST, HIV DETECTION

Model Number N/A

Device Problem False Negative Result (1225)

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

Event Date 10/11/2023

Event Type  malfunction  

Event Description

The customer reported one (1) false negative (non-reactive) hiv ag/ab combo (chiv) patient sample result was obtained on an advia centaur cp.The result was considered discordant compared to a result from alternate methods.The patient sample was received from a different lab for hiv (confirmatory) testing.The referring lab had initially tested the sample on their alternate instrument and obtained a positive (reactive) result for hiv.The patient sample was first run on an alternate instrument and a positive (reactive) hiv result was obtained.The same sample was run on the advia centaur cp within the same lab and a negative (non-reactive) chiv result was obtained.The non-reactive result was not reported to the physician.The reactive results obtained from the alternate instruments were considered correct.There are no known reports of patient intervention or adverse health consequences due to the false negative chiv result.

Manufacturer Narrative

The customer from outside the united states reported one (1) false negative (non-reactive) hiv ag/ab combo (chiv) result was obtained on an advia centaur cp.The result was considered discordant compared to a result from alternate methods.The non-reactive result was not reported to the physician.The reactive results obtained from the alternate instruments were considered correct.Siemens has evaluated the instrument, reagent and sample data.Reagent issues were ruled out based on review of qc which showed recovery within acceptable ranges and no issues were reported with other patient samples.Based on the available information, the cause of the discordant result is unable to be determined.The calculated values for anti-hiv and/or p24 antigen in each specimen as determined by assays from different manufacturers can vary due to differences in assay methods and reagent specificity.Sample return for further investigation is not possible as sample is not available.The customer is operational.The limitations section of the advia centaur cp hiv ag/ab combo (chiv) instructions for use (ifu) states the following: ¿the calculated values for anti-hiv and/or p24 antigen in a given specimen as determined by assays from different manufacturers can vary due to differences in assay methods and reagent specificity.The results reported by the laboratory to the physician must include the identity of the assay used.Values obtained with different assay methods cannot be used interchangeably.The reported antibody level and/or p24 antigen cannot be correlated to an endpoint titer.¿ additionally, the limitations section of the ifu states: ¿currently available assays for the detection of p24 antigen and/or antibodies to hiv-1 and/or hiv-2 may not detect all infected individuals.A negative test result does not exclude the possibility of exposure to or infection with hiv.Hiv antibodies and/or p24 antigen may be undetectable in some stages of the infection and in some clinical conditions.¿.

• Brand Name: ADVIA CENTAUR HIV AG/AB COMBO (CHIV)
• Type of Device: TEST, HIV DETECTION
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney st.; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney st.; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 18109319
• MDR Text Key: 328669237
• Report Number: 1219913-2023-00286
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2023
• Device Model Number: N/A
• Device Catalogue Number: 10283020
• Device Lot Number: 336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2023
• Date Device Manufactured: 01/25/2023
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Sex: Male