MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT 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 04/26/2019

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant advia centaur xp hiv ag/ab combo (chiv) results is unknown.Siemens is investigating.The limitations section of the instruction for use (ifu) n states the following: "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 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.".

Event Description

The customer obtained an advia centaur xpt hiv ag/ab combo (chiv) (b)(6) result on a patient sample that was (b)(6) upon repeat testing on the advia centaur xpt and on an alternate method.There are no reports that treatment was altered or prescribed or adverse health consequences due to the (b)(6) advia centaur xpt chiv result.

Manufacturer Narrative

Mdr was filed on may 21, 2019 reporting a non-reactive result on the advia centaur xpt chiv assay.The sample yielded a reactive result on two alternate methods.Additional information may 22, 2019: the customer contact name was not available at the initial filing.It has since been provided.The customer contact name is mrs (b)(6) and telephone number is (b)(6).

Manufacturer Narrative

Mdr (b)(4) was filed on (b)(6)2019 reporting a non-reactive result on the advia centaur xpt chiv assay.The sample yielded a reactive result on two alternate methods.Mdr (b)(4) supplemental 1 was filed on (b)(6)2019 with the customer contact name and telephone number.Additional information - (b)(6)2019 siemens requested additional information from the customer multiple times to investigate this complaint.Additionally, siemens requested the sample but the sample was not provided for additional testing, therefore siemens is not able to determine root cause.Based on the information in the complaint, siemens is unable to rule out sample specific issue such as pre-analytical factors.The customer is operational.Based on the information provided, no product problem identified.No further investigation is needed.

• Brand Name: ADVIA CENTAUR XPT HIV AG/AB COMBO (CHIV) ASSAY
• Type of Device: CHIV IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591
• MDR Report Key: 8627162
• MDR Text Key: 145760631
• Report Number: 1219913-2019-00080
• 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: 07/02/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2019
• Device Model Number: N/A
• Device Catalogue Number: 10283020
• Device Lot Number: 87301177
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/02/2019
• Initial Date FDA Received: 05/21/2019
• Supplement Dates Manufacturer Received: 05/22/2019; 06/28/2019
• Supplement Dates FDA Received: 06/14/2019; 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1