MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPTHCV (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 06/22/2018

Event Type  malfunction  

Manufacturer Narrative

The cause for the (b)(6) advia centaur xpt (ahcv) result compared to (b)(6) alternate hcv test method results is being investigated by siemens.The instruction for use (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.Assay performance characteristics have not been established when the advia centaur hcv assay is used in conjunction with other manufacturers' assays for specific hcv serological markers." mdr 1219913-2018-00202 was filed for the same patient for a (b)(6) result on (b)(6) 2018.

Event Description

A (b)(6) advia centaur xpt hcv (ahcv) result was obtained by the customer, and the result was questioned by the physician.The patient was first tested on an alternate hcv test method, and the result (b)(6).A new sample from the same patient was drawn, and tested on the advia centaur xpt that resulted (b)(6).The patient sample was tested on another hcv test method, and the result was (b)(6).A corrected report was issued.There are no reports that patient treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xpt hcv results.Mdr 1219913-2018-00202 was filed for the same patient for a (b)(6) result on (b)(6) 2018.

Manufacturer Narrative

11/12/2018 additional information: the sample was provided, and was tested on the advia centaur xpt, and the innolia platforms.The sample was considered positive on innolia, and a high negative when tested on the advia centaur xpt.The advia centaur xpt hcv assay detects antibodies to several different hcv antigens including c22, c200 and ns5.A study was performed, and reactivity to the c22 and c200 antigens was observed.Based on the index value of the sample, it is possible that this is a very old hcv infection; however patient history or preexisting medical condition including medications, and dates of diagnosis was not provided in determining a potential root cause.There is no indication by the customer that the instruction for use (ifu) for clinical sensitivity is outside the 95% confidence interval (ci) of 99.18 to 100%.Hcv sample testing results: platform reagent lot result advia centaur xpt 062294 0.70 index (non-reactive), advia centaur xpt 062286 0.66 index (non-reactive), innolia hcv score: n/a +/- reactivity to c1 and c2 lines.Antigens (c22, c2000, ns5) reactivity study: c22 specific wetcakes 11.0 rlu sd (reactivity), c200 specific wetcakes 16.1 rlu sd (reactivity), ns5 ancillary reagent -0.99 rlu sd (no reactivity).Note: reactivity was classified as >10 rlu sd above normal patient baseline.The instruction for use (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.Assay performance characteristics have not been established when the advia centaur hcv assay is used in conjunction with other manufacturers' assays for specific hcv serological markers." the instrument is performing within specification.No further evaluation of the device is required.Mdr 1219913-2018-00202 was filed on the same patient for a false non-reactive result on a different day.

• Brand Name: ADVIA CENTAUR XPTHCV (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: 7749132
• MDR Text Key: 116714167
• Report Number: 1219913-2018-00199
• 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
• Report Date: 11/14/2018

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: 11/10/2018
• Device Model Number: N/A
• Device Catalogue Number: 10309061
• Device Lot Number: 062286
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/03/2018
• Supplement Dates Manufacturer Received: 11/12/2018
• Supplement Dates FDA Received: 11/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR