MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS ATELLICA IM 1600 HIV AG/AB COMBO (CHIV); HIV AG/AB COMBO ASSAY

Model Number N/A

Device Problem False Negative Result (1225)

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

Event Date 01/11/2023

Event Type  malfunction  

Manufacturer Narrative

An outside the united states customer obtained a nonreactive (negative) hiv ag/ab combo (chiv) result for a patient sample on atellica im.The sample was repeated on the same atellica im and the result was also negative.The sample was tested on two other alternate methods and the results were positive.Calibration and quality control (qc) were within the range.The interpretation of results section of the atellica im chiv instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." catalog#10995527 is not registered in the us, however, pma bp140103 for a similar product (atellica im hiv ag/ab combo (chiv) catalog# 10995459) siemens continues to investigate.

Event Description

The customer obtained a nonreactive (negative) hiv ag/ab combo (chiv) result for a patient sample on atellica im.The sample was repeated on the same atellica im and the result was also negative.The sample was tested on two other alternate methods and the results were positive.The atellica im chiv results were not reported to the physician(s).There are no reports that treatment was altered or prescribed or adverse consequences due to the discordant nonreactive atellica im chiv results.

Manufacturer Narrative

Siemens filed the initial mdr on feb 16, 2023.Additional information feb 17, 2023: an outside the united states customer obtained a nonreactive (negative) hiv ag/ab combo (chiv) result using lot 321 on a patient sample on atellica im.The sample was repeated on the same atellica im and the result was also negative.The sample was tested on two other alternate methods and the results were positive.Siemens reviewed the available information to evaluate for a potential product problem.Qc was within acceptable range for atellica im chiv.No sample was available to send to siemens for further investigation to determine potential cause.Sample was from a known hiv positive patient.The patient is not known to be on anti-retroviral therapy but this cannot be ruled out and can be a cause for false non-reactive results.Intended use of atellica im chiv is to diagnose not to monitor positive patients.No potential product issue is observed.The customer is operational.In section h6, the investigation finding, and investigation conclusion codes were updated.

• Brand Name: ATELLICA IM 1600 HIV AG/AB COMBO (CHIV)
• Type of Device: HIV AG/AB COMBO ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 7818564812
• MDR Report Key: 16386341
• MDR Text Key: 309662818
• Report Number: 1219913-2023-00020
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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,Followup
• Report Date: 03/10/2023

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: 05/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995527, SEE SECTION H10
• Device Lot Number: 325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2022
• 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