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

Model Number	N/A
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer from united states reported discordant false negative (non-reactive) atellica hiv ag/ab combo (chiv) lot 344 results on samples from a known positive hiv-1 patient compared to positive (reactive) results on alternate test methods.Quality control (qc) recovery was within the customer's established ranges.A siemens customer service engineer (cse) was dispatched to the customer's site and found the precision for the test was higher than expected.The cse changed the calibrator and reagent pack and re-calibrated the assay.After this routine troubleshooting intervention, the precision was improved, and the instrument was operational.The interpretation of results section of the atellica im hiv ag/ab combo (chiv) instructions for use (ifu) states the following: ¿results of this assay should always be interpreted in conjunction with the patient¿s medical history, clinical presentation, and other findings.¿ siemens continues to investigate the event.One mdr is being filed for each of discordant results obtained (this mdr is for sample 801059211002, result obtained (b)(6) 2023).
Event or Problem Description
The customer obtained discordant false negative (non-reactive) hiv ag/ab combo (chiv) lot 344 results on samples from a known positive hiv-1 patient when processed on an atellica im 1300 analyzer (s/n: (b)(6) ).The initial testing was performed on an alternate method that resulted positive (reactive).The same sample (serum) was tested with atellica im chiv lot 344, and a negative (non-reactive) discordant result was obtained.A different sample (plasma) was obtained and was also tested in 2 replicates with atellica im chiv lot 344.One result was negative (non-reactive) and one result was positive (reactive).Both serum and plasma samples were retested on the alternate method, and both resulted as positive (reactive) result.Both serum and plasma samples were tested on a different alternate method and were confirmed positive (reactive).The atellica im chiv negative results were not reported to the physician.The patient was reported out as positive, which is consistent with patient history.There are no known reports of patient intervention or adverse health consequences due to the discordant negative chiv results.
Additional Manufacturer Narrative
The initial mdr 1219913-2024-00002 was filed on 08-jan-2024.Additional information on 10-jan-2024: siemens concluded the investigation for discordant non-reactive result on a known positive hiv-1 patient with atellica hiv ag/ab combo (chiv) lot 344 compared to reactive result on alternate test methods.Quality control (qc) was within expected limits and no other samples were affected.A siemens customer service engineer (cse) was dispatched to the customer's site and found the precision for the test was higher than expected.The cse inspected reagent, aspirate probes, performed cleaning of wash block and reagent wash bowls.Autocheck and background check were performed, and all results were within passing range.The cse changed the calibrator and reagent pack and re-calibrated the assay.After this routine troubleshooting intervention, the precision was improved, and the instrument was operational.The patient is known to be on anti-retroviral therapy which can cause false non-reactive results.Based on the available information, the cause of the discordant result is unable to be determined but siemens cannot rule out sample handling.A product problem has not been identified.The customer is operational.Mdr 1219913-2024-00003 supplement 1 report was filed for sample (b)(6), result obtained 06-dec-2023.

• Brand Name: ATELLICA IM HIV AG/AB COMBO (CHIV)
• Common Device Name: 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: stacy loukos ; 333 coney st.; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 18471063
• Report Number: 1219913-2024-00002
• Device Sequence Number: 6775440
• Product Code: MZF
• UDI-Device Identifier: 00630414600390
• UDI-Public: 00630414600390
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: BP140103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/16/2024
• Device Model Number: N/A
• Device Catalogue Number: 10995459
• Device Lot Number: 344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown