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

Model Number N/A

Device Problems False Negative Result (1225); Use of Device Problem (1670)

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

Event Date 06/02/2023

Event Type  malfunction  

Manufacturer Narrative

An outside of the united states (ous) customer contacted a siemens customer care center (ccc) to report false negative (non-reactive) results on 2 serum samples from the same patient using atellica im (s/n (b)(6)) hiv ag/ab combo (chiv), reagent lot 335.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 limitations section of the chiv instructions for use (ifu) states, "the performance of the assay has not been established with infants." the storing the specimen section of the chiv ifu states, "store processed specimens capped at all times at 2¿8°c for up to 14 days." the interpretation of results section of the chiv 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) is associated with similar product in the united states: catalog number 10995459 / premarket approval (pma)# bp140103).Siemens is investigating.

Event Description

The customer obtained false negative (non-reactive) results on serum samples from the same patient on different days using atellica im hiv ag/ab combo (chiv), reagent lot 335.The samples resulted as reactive on alternate test methods.The reactive results were considered correct.It is unknown if the non-reactive results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the non-reactive chiv results.

Manufacturer Narrative

Siemens filed mdr 1219913-2023-00132 initial report with the fda on 2023-07-09.Additional information - 2023-08-01 siemens has concluded investigation for a customer observation for atellica im hiv ag/ab combo (chiv), reagent lot 335, non-reactive results on two samples from the same patient, which were reactive on alternate methods.Siemens' investigation included an assessment of reagent, instrument, and sample data.Reagent and instrument issues were ruled out based on review of quality control (qc) which showed recovery within acceptable ranges and no issues were reported with other patient samples.The sample results were also reproducible on atellica im platform.Per the storing the specimen section of the chiv instructions for use (ifu), "store processed specimens capped at all times at 2¿8°c for up to 14 days." both samples were past this stability requirement when run on atellica im chiv.Per the limitations section of the ifu, "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." return of the patient sample for further investigation is not warranted because sample(s) has exceeded stability specifications.Based on the available information, the cause of the discordant result is consistent with sample stability and/ or differences in manufacturer methods.A product performance issue has not been identified.The customer is operational.The sections listed below have been updated in this report to reflect additional information provided to siemens since initial reporting of this event in mdr1219913-2023-00132, filed with the fda on 2023-07-09: section b5 - the initial, discordant results were reported and questioned by the physician.Section b7 - the patient was not 18 or 15 days old.The samples are different blood draws from the same patient.The samples were tested 18 and 15 days after they were drawn.Section d8 - no 3rd party service was provided.Section e1 - name of facility and name of customer contact was updated from nhls and dr george mukhari to "nhls dr george mukhari" and "norman mkize".Phone number was added.Section h6, the medical device problem, investigation finding, and investigation conclusion codes were updated.Mdr 1219913-2023-00131 supplemental 1 report was filed for the same event.

Event Description

The initial, discordant results were reported and questioned by the physician.

• 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: 17287263
• MDR Text Key: 319017883
• Report Number: 1219913-2023-00132
• 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: 08/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• 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: 10995527
• Device Lot Number: 335
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/01/2023
• 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