MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP HIV AG/AB COMBO (CHIV) ASSAY; CHIV IMMUNOASSAY

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant advia centaur cp (b)(6) results is unknown.Siemens healthcare diagnostics is investigating.The ifu states in the limitations section: "the calculated values for (b)(6) 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.Currently available assays for the detection of p24 antigen and/or antibodies to (b)(6) and/or (b)(6) may not detect all infected individuals.A negative test result does not exclude the possibility of exposure to or infection with (b)(6).(b)(6) antibodies and/or p24 antigen may be undetectable in some stages of the infection and in some clinical conditions." mdr 1219913-2019-00220 ((b)(6) 2019 repeat result) was filed for the same event.

Event Description

A false negative advia centaur cp (b)(6) ag/ab combo ((b)(6)) result was obtained on a patient sample on (b)(6) 2019.The same sample was previously tested on the atellica im system on (b)(6) and (b)(6) 2019; and the results were positive.The customer had repeated the sample on the advia centaur cp because the values for the atellica im result had decreased in comparison to the values of a previous sample that was tested on (b)(6) 2019.The customer repeated the sample on the advia centaur cp on (b)(6) 2019 and the result was negative.The customer reported the positive result from the atellica im system.The customer had processed viral charge on an alternate method for the previous sample with a result of 10^6 and western blot: p24, p31, gp160, gp140 and gp36 were negative and gp41 positive.The customer reported the result as indeterminate and asked for a new sample.The customer processed viral charge on the second sample with a result of 10^4 and western blot: positive for all except gp140 and gp36 that were negative.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant advia centaur cp (b)(6).

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00219 on october 23, 2019.01/23/2020 additional information: the patient sample was received by siemens and tested on both the advia centaur cp and atellica im platforms.The results have been summarized below: advia centaur cp chiv lot 117232: 1.29 index.Atellica im chiv lot 117233: 1.36 index.Atellica im ehiv lot 103264: 20.4 index.The sample was then tested in separate solid phase components of the ehiv and chiv assay.The sample was highly reactive with the ehiv p24 antibody portion of the solid phase and was nonreactive with chiv p24 antigen portion of the solid phase.The decreasing index on observed with the chiv assay on the advia centaur cp and atellica im is because of the neutralization of the p24 antigen.Ehiv has a different assay architecture and detects p24 antibody.Based on the results generated by siemens, the observation of a non-reactive results was not confirmed.Based on the information available, no product problem identified.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2019-00220 supplemental report 1 was filed for the same event.

• Brand Name: ADVIA CENTAUR CP HIV AG/AB COMBO (CHIV) ASSAY
• Type of Device: CHIV IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 9225179
• MDR Text Key: 220623581
• Report Number: 1219913-2019-00219
• Device Sequence Number: 1
• Product Code: MZF
• Combination Product (y/n): N
• PMA/PMN Number: BP140103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 10283020
• Device Lot Number: 66007201
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1