MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM 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 07/14/2023

Event Type  malfunction  

Event Description

The customer obtained a false negative (non-reactive) result on a patient sample using atellica im hiv ag/ab combo (chiv), reagent lot 335, compared to the reactive result on alternate test methods.There are no known reports of patient intervention or adverse health consequences due to the non-reactive chiv results.

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc) to report a false negative (non-reactive) result on a patient sample using atellica im hiv ag/ab combo (chiv), reagent lot 335, compared to the reactive result on alternate test methods.The customer uses the alternate method as first line screening and samples that are initially reactive are processed on the atellica im to confirm the results.The interpretation of results section of the chiv instructions for use (ifu) states, "results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings." this ous product (catalog number 10995527, as listed in d4 of this report) is associated with similar product in the united states: catalog number 10995459 / premarket approval (pma)# bp140103).Siemens is investigating.

Manufacturer Narrative

Siemens filed mdr 1219913-2023-00165 initial report with the fda on 11-aug-2023.Additional information ¿ 02-nov-2024.Siemens concluded the investigation for an outside of the us (ous) customer observation of a false non-reactive result on a patient sample using atellica im hiv ag/ab combo (chiv), reagent lot 335, compared to the reactive result on alternate test methods.Quality control (qc) was within expected limits.There was insufficient sample remaining to be sent to siemens for further testing.The patient was not on anti-retroviral therapy.Probable cause of the non-reactive result is unknown, however, a sample specific interferent cannot be ruled out.Based on the investigation, a product problem was not identified.The customer is operational.In section h6, the investigation finding and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM 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.; registration #: 1219913; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 17509550
• MDR Text Key: 321714378
• Report Number: 1219913-2023-00165
• 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,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• 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: 10995527
• Device Lot Number: 335
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female