MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP HCV (AHCV) ASSAY; HEPATITIS C VIRUS (ANTI-HCV) ASSAY

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 07/09/2018

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant (b)(6) results is unknown.Siemens healthcare diagnostics has requested the patient samples for further testing and investigation.The ifu states in the limitations section: "a negative test result does not exclude the possibility of exposure to or infection with hcv.Hcv antibodies may be undetectable in some stages of the infection and in some clinical conditions." mdr 1219913-2018-00186, mdr 1219913-2018-00190, mdr 1219913-2018-00191, mdr 1219913-2018-00192, and mdr 1219913-2018-00193 were filed for the same event.

Event Description

Discordant (b)(6) results were obtained on samples from a known (b)(6) patient.The patient samples were tested on alternate method and the results were (b)(6).The pcr testing performed was (b)(6).The result from the (b)(6) testing was indeterminate.The previous results from 2013 to 2015 for the patient from alternate methods were (b)(6).Patient treatment was not altered or prescribed.There was no report of adverse health consequences due to the discordant (b)(6) result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2018-00194 on (b)(6) 2018.Siemens filed the mdr 1219913-2018-00194 supplemental report 1 on (b)(6) 2018.On (b)(6) 2018 additional information: siemens has completed the testing and investigation into the discordant negative hcv patient sample.Testing on the inno-lia demonstrated a negative hcv score with all antigen bands showing a negative reactivity.The patient sample was then tested on the advia centaur xp with ahcv lot 294 (available lot) using antigen specific solid phases.The solid phases tested were control (standard readypack), c22, c200, and ns5 wetcakes.The patient sample showed similar recovery to a pool of 20 hcv negative patients.The testing showed negative inno-lia hcv score, negative reactivity to ahcv lot 294 reagent on the advia centaur xp, and no reactivity to antigen specific wetcakes.This could be a case of an initial false positive on the alternate, initial testing platform.The cause for the discordant hcv results is unknown.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2018-00186 supplemental report 2, mdr 1219913-2018-00190 supplemental report 2, mdr 1219913-2018-00191 supplemental report 2, mdr 1219913-2018-00192 supplemental report 2, and mdr 1219913-2018-00193 supplemental report 2 were filed for the same event.

Manufacturer Narrative

Siemens filed the initial mdr on july 18, 2018.08/03/2018 additional information: the customer's decision was to report the final result as positive based on historical data and the result of elisa kit hcv murex that is used as confirmation.The patient sample was received for further testing and investigation at the manufacturer's site.Mdr 1219913-2018-00186 supplemental report 1, mdr 1219913-2018-00190 supplemental report 1, mdr 1219913-2018-00191 supplemental report 1, mdr 1219913-2018-00192 supplemental report 1, and mdr 1219913-2018-00193 supplemental report 1 were filed for the same event.

• Brand Name: ADVIA CENTAUR XP HCV (AHCV) ASSAY
• Type of Device: HEPATITIS C VIRUS (ANTI-HCV) ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7701059
• MDR Text Key: 114683669
• Report Number: 1219913-2018-00194
• Device Sequence Number: 1
• Product Code: MZO
• UDI-Device Identifier: 00630414473161
• UDI-Public: 00630414473161
• Combination Product (y/n): N
• PMA/PMN Number: P030056
• 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: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/02/2019
• Device Model Number: N/A
• Device Catalogue Number: 10309061
• Device Lot Number: 93920288
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR