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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

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

Event Date 06/29/2019

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant advia centaur cp chiv results is unknown.Siemens healthcare diagnostics has requested the patient sample for further testing and investigation.The ifu states in the limitations section: "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 (b)(6) 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." mdr 1219913-2019-00174 (september 4th repeat testing) was filed for the same event.

Event Description

A false (b)(6) advia centaur cp hiv ag/ab combo (chiv) result was obtained on a patient sample.The patient sample was repeated with the advia centaur cp hiv ag/ab combo (chiv) assay at a later date and the result was (b)(6).The patient sample was tested on three alternate methods and the results were (b)(6).A corrected report was issued.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant advia centaur cp chiv.

Manufacturer Narrative

Siemens filed the initial mdr on september 25, 2019.11/13/2019 additional information: siemens attempted to acquire the necessary information to investigate this issue on 9/23/2019, 10/02/2019 and again on 10/29/2019.No feedback or response was provided by the region.False non-reactive (negative) results obtained with advia centaur cp chiv lot 117191.The same sample resulted reactive with elisa and western blot.The customer service engineer (cse) has gone onsite and found electricity grounding was out of instrument specifications.The team resolved this issue and replaced major parts on the system.The team feels the issue was random with very low frequency and most probably due to spiking of the grounding voltage.The advia centaur cp chiv ifu (10629936_en rev.J, 2019-08) states the intended use of the assay is to aid in the diagnosis of hiv infection: "the advia centaur hiv ag/ab combo (chiv) assay is an in vitro diagnostic immunoassay for 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 serum and plasma (potassium-edta) to aid in the diagnosis of hiv infection, using the advia centaur cp system." the 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 service activity related to this complaint, it is inconclusive to determine what mechanical malfunction could have contributed to the false non-reactive result.The system is operational.No product problem identified.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2019-00174 supplemental report 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: 9118766
• MDR Text Key: 214799995
• Report Number: 1219913-2019-00173
• 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: 12/06/2019

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: 09/19/2019
• Device Model Number: N/A
• Device Catalogue Number: 10283020
• Device Lot Number: 36109191
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/11/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 11/13/2019
• Supplement Dates FDA Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1