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 09/27/2023

Event Type  malfunction  

Event Description

The customer obtained non-reactive (negative) atellica im hiv ag/ab combo (chiv) initial results on a sample from one patient who was suspected of being positive.The initial results were not reported to the physician.The sample was retested with 2 alternate methods, both of which results positive.There are no allegations of patient or user intervention or adverse health consequences due to the false negative chiv results.

Manufacturer Narrative

On outside of the united states (ous) customer observed non-reactive atellica im hiv ag/ab combo (chiv) results on a patient compared to the reactive result obtain using two alternate test methods.Siemens investigated the event.Quality control (qc) was in range when the sample was tested.No other samples were affected, and the result was reproducibly non-reactive on atellica im chiv.No sample was remaining for further testing by siemens.The specimen was from an infant from an hiv positive mother.The limitations section of the instructions for use (ifu) states: "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."the performance of the assay has not been established with infants." the interpretation of results section of the ifu states: "results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings." based on the investigation, no product performance issue was identified.The customer is operational.Section g4 lists the pma/510(k)number of similar us product (siemens material number 10995459).

• 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
• MDR Report Key: 18011378
• MDR Text Key: 326615560
• Report Number: 1219913-2023-00269
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: BP140103
• 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: 10/26/2023

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: 11/25/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995527
• Device Lot Number: 335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2023
• Initial Date FDA Received: 10/26/2023
• 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