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

Model Number N/A

Device Problem False Positive Result (1227)

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

Event Date 12/30/2021

Event Type  malfunction  

Event Description

The customer obtained a positive atellica im hiv ag/ab combo (chiv) result for a 49-year-old female patient that was negative upon confirmation testing with an alternate test method.The customer alleged that the patient was denied kidney transplant based on the positive chiv screening result.The customer stated that the negative confirmatory result on the alternate test method was a send out so took a week for final result.This same patient was tested approximately 7 months later and a positive atellica im hiv ag/ab combo (chiv) result was obtained again, and the alternate method confirmatory testing was negative again.There are no reports by the customer of adverse health consequences due to discordant chiv results.

Manufacturer Narrative

A united states customer contacted siemens to report discordant atellica im hiv ag/ab combo (chiv) results on 2 different serum samples from the same patient.The customer uses siemens chiv quality control (qc) and there is no concern with the qc results.Patient samples are respun for 10 minutes at 5000 rpm.The following is from the atellica im hiv ag/ab combo (chiv) instructions for use (ifu): "specimens with an index value >/= 1.0 are considered initially reactive for p24 antigen and/or antibodies to hiv 1 and/or hiv 2 and should be retested in duplicate after centrifugation at 10,000 x g for 10 minutes.If one or both of the duplicates are reactive, the specimen is repeatedly reactive by the atellica im chiv assay.Note: inadequate centrifugation may result in a higher rate of repeat reactive results that must be investigated using supplemental tests for hiv 1 and/or hiv 2 and/or p24 antigen.Repeatedly reactive specimens must be investigated using supplemental tests for hiv 1 and/or hiv 2 and/or p24 antigen.In specimens giving indeterminate supplemental test results, testing of a subsequent sample drawn at a later date (such as 1-6 months) is recommended." "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens' initial review of the complaint information indicates that it appears samples that are reactive for chiv are being spun at half of the recommended centrifugation speed listed in the instructions for use, which can cause a higher rate of repeat reactive results.Siemens is investigating.Mdr 1219913-2022-00276 was filed for the same incident.

Manufacturer Narrative

Siemens healthcare diagnostics filed mdr initial report on (b)(4).Additional information - 2022-09-10.The atellica im chiv initial positive (reactive) result obtained on 2021-12-30 was tested on instrument serial number irh010202016.The actual value, sample id and reagent lot number were not provided for this sample.Additional information - 2022-09-14.Siemens concluded the investigation for a united states (us) customer observation of reactive atellica im hiv ag/ab combo (chiv) results that were non-reactive in confirmatory testing.Siemens reviewed the available information to evaluate for a potential product problem.The chiv quality control (qc) was in range at the time of the event.No additional sample was remaining from this patient for further investigation.A medication list and diagnosis are not available for the patient.The patient was awaiting an organ transplant and the elevated result due to an interfering substance or antibody cannot be ruled out.Per the limitations section of the atellica im chiv instructions for use (ifu), "heterophilic and hama antibodies in human samples can react with reagent antibodies, interfering with in vitro immunoassays.Patients routinely exposed to animals or to animal serum products for diagnosis or therapies can be prone to this interference and anomalous values may be observed.Specimens from patients who have received mouse monoclonal antibodies for diagnosis or therapy may contain human anti-mouse antibodies and may interfere in assays that employ mouse monoclonal antibodies.Additional information may be required for diagnosis." the customer does not follow the ifu recommendations for sample centrifugation after initial elevated results.Inadequate centrifugation may result in a higher rate of repeat reactive results that must be further investigated by alternate methods.The customer has reviewed their testing rate of reactive and nonreactive samples and believes they are falling within sensitivity and specificity expectations for the assay, as described in the ifu.Based on the investigation, no product problem was identified.The customer is operational.In section h6, investigation finding and investigation conclusion codes were updated based on the investigation results.Mdr 1219913-2022-00276 supplemental 1 report was filed for the same incident.

• Brand Name: ATELLICA IM HIV AG/AB COMBO (CHIV)
• Type of Device: CHIV IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: stacy loukos ; 333 coney street; east walpole, MA 02032 ; 3392064073
• MDR Report Key: 15386774
• MDR Text Key: 304515755
• Report Number: 1219913-2022-00275
• Device Sequence Number: 1
• Product Code: MZF
• UDI-Device Identifier: 00630414600390
• UDI-Public: 00630414600390
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BP140103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10995459
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Age: 49 YR
• Patient Sex: Female