MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM 1600 HIV AG/AB COMBO (CHIV); 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 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant atellica im 1600 chiv result is unknown.Siemens is investigating.Siemens filed mdrs 1219913-2018-00107, 1219913-2018-00110 and 1219913-2018-00119 on march 16, 2018 for advia centaur chiv nonreactive results from the same patient.The patient was identified as an "elite controller".The limitations section of the instructions for use states: "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." "currently available assays for the detection of p24 antigen and/or antibodies to (b)(6) may not detect all infected individuals.A (b)(6) 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.".

Event Description

Customer observed a nonreactive result on the atellica im 1600 (b)(6) ag/ab combo (chiv) assay that was reactive on an alternate method.The patient is known to be seropositive for (b)(6).There are no reports that treatment was altered or prescribed or adverse health consequences due to the nonreactive atellica im 1600 chiv result.

Manufacturer Narrative

Siemens filed mdr 1219913-2019-00279 on december 18, 2019 reporting a discordant atellica im 1600 chiv compared to an alternate method.Mdr 1219913-2019-00279 supplemental 1 was filed on january 13, 2020 with additional information.February 3, 2020 - additional information: as stated in b7 of the initial mdr 1219913-2019-00279, this patient had previously been tested on the siemens' advia centaur chiv assay and also obtained negative results.Siemens filed those results with fda under mdrs 1219913-2018-00107, 1219913-2018-00110 and 1219913-2018-00119 on march 16, 2018.The patient is considered an "elite controller", which is defined as a very small subset of people infected with hiv who are able to maintain suppressed viral loads for years without antiretroviral therapy (art).However, because hiv continues to replicate even in elite controllers, art is recommended for those rare controllers who have declining cd4 counts or who develop hiv-related complications.The customer provided the additional information that this patient is followed for hiv seroconversion because she is positive to p24 ac and non p24 ang.Siemens performed multiple investigations of this patient under mdr 1219913-2018-00107, 1219913-2018-00110 and 1219913-2018-00119.Results of the investigations indicate that the patient sample may be a p24-antibody only sample.The primary purpose of the atellica im chiv assay is to aid in the diagnosis of hiv infection.Chiv assay is a combo assay, it only has the architecture to detect p24 antigen.The intended use section of the atellica im chiv instructions for use states: "the atellica im hiv ag/ab combo (chiv) assay is for in vitro diagnostic use in the simultaneous qualitative detection of human immunodeficiency virus p24 antigen and antibodies to human immunodeficiency viruses type 1 (including group "o") and type 2 in human serum and plasma ( edta) to aid in the diagnosis of hiv infection using the atellica im analyzer." the atellica im chiv ifu states in the limitations section "currently available assays for the detection of p24 antigen and/or antibodies to hiv-1 and/or hiv-2 may not detect all infected individuals.A negative test result does not exclude the possibility of exposure to or infection with hiv.Hiv antibodies and/or p24 antigen may be undetectable in some stages of the infection and in some clinical conditions." based on the information provided the atellica im chiv assay is meeting claims.

Manufacturer Narrative

Siemens filed mdr 1219913-2019-00279 on december 18, 2019 reporting a discordant atellica im 1600 chiv compared to an alternate method.December 20, 2019 - additional information: as stated in b7 of the initial mdr 1219913-2019-00279, this patient had previously been tested on the siemens' advia centaur chiv assay and also obtained negative results.Siemens filed those results with fda under mdrs 1219913-2018-00107, 1219913-2018-00110 and 1219913-2018-00119 on march 16, 2018.The patient was identified as an "elite controller".The customer provided the additional information that this patient is followed for hiv seroconversion because she is positive to p24 ac and non p24 ang.As stated in the intended use section of the instructions for use (b)(4), 'the atellica im hiv ag/ab combo (chiv) assay is for in vitro diagnostic use in the simultaneous qualitative detection of human immunodeficiency virus p24 antigen and antibodies to human immunodeficiency viruses type 1 (including group "o") and type 2 in human serum and plasma (edta), to aid in the diagnosis of hiv infection, using the atellica im analyzer.' siemens continues to investigate.

• Brand Name: ATELLICA IM 1600 HIV AG/AB COMBO (CHIV)
• Type of Device: CHIV IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 9491686
• MDR Text Key: 220782584
• Report Number: 1219913-2019-00279
• 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,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/12/2020
• Device Model Number: N/A
• Device Catalogue Number: 10995527
• Device Lot Number: 42016222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1