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

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 12/09/2019

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant (b)(6) results is unknown.Siemens healthcare diagnostics is investigating.The ifu states in the limitations section: "a negative test result does not exclude the possibility of exposure to or infection with (b)(6).(b)(6) antibodies may be undetectable in some stages of the infection and in some clinical conditions.".

Event Description

A discordant low result was obtained for one patient using the advia centaur xpt (b)(6) immunoassay.An initial result of >11 index (reactive) was obtained and was retested because the patient was new to the laboratory and because the interpretation of results section of the instructions for use (ifu) states, "samples with a calculated value greater than or equal to 1.00 index value are considered reactive for igg antibodies to hcv.It is recommended that the sample be repeated in duplicate." a non-reactive result was obtained with the retest.Both the initial and retest results were reported to the physician, who questioned the non-reactive result.Due to the discordance, a new sample was obtained from the same patient.Reactive results were obtained with this new sample, which was reported to the physician.All results were obtained on the same day, on the same instrument.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant (b)(6) result.

Manufacturer Narrative

Siemens filed mdr 1219913-2019-00284 initial report on december 27, 2019.Additional information 01/28/2020: the complaint was initiated due to an advia centaur xpt hcv false negative patient result of >11 index using reagent lot 331, which repeated as 0.19 index.The country states that service did not find anything wrong with the instrument as part of the on site evaluation (aspiration/dispensation verification on the wash station, cleaning of all probes and covers and aspiration dispensation of acid and base).All repeatability tests performed by the field service engineer were acceptable.Based on the fact that the discordant result was isolated to a single patient sample result, it is inconclusive to determine probable cause.Historically when there is a false reactive with an hcv patient sample result there is a high probability it is caused by lack of sample delivery due to the small sample size of 10ul however it is inconclusive in this case.The country states that there were no failures reported from an instrument perspective as a result of the service inspection.The customer system is currently functional and all repeatability tests and verifications were acceptable.Based on evaluation of the complaint file there are no potential product issues identified.No further investigation is required.

• Brand Name: ADVIA CENTAUR XPT 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: 9526470
• MDR Text Key: 219579675
• Report Number: 1219913-2019-00284
• 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: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2020
• Device Model Number: N/A
• Device Catalogue Number: 10309061
• Device Lot Number: 10092331
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR