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 Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 07/02/2014

Event Type  malfunction  

Event Description

A sample result was (b)(6) with the advia centaur xp hcv assay and repeated as (b)(6) on the advia centaur xp hcv assay.There are no reports that treatment was altered or prescribed based on the (b)(6) result.There are no reports of adverse health consequences based on the discordant (b)(6) advia centaur xp hcv result.

Manufacturer Narrative

The cause for the discordant (b)(6) advia centaur hcv result is unknown.Service was sent on site and evaluated the instrument at the following points: luminometer background count check with and without cuvettes vacuum.Dispense of r1, r2, r3 and ancillary probes, acid and base dispense electrovalues of both manifolds, dispense and aspiration of the four aspiration probes, wash of aspiration probes, general tubings and connections checked for leaking.Some wash guides were changed due to the observation of precipitate.No conclusions can be drawn.Sample is not available for testing.The quality control results were within range and the runs are considered valid.The instrument is performing within specification.The issue appears to be specific to this patient sample.The limitations section of the instructions for use states: "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.Assay performance characteristics have not been established when the advia centaur hcv assay is used in conjunction with other manufacturers' assays for specific (b)(6) serological markers.".

• Brand Name: ADVIA CENTAUR XP HCV (AHCV) ASSAY
• Type of Device: HEPATITIS C VIRUS (ANTI-HCV) ASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC; 333 coney street; east walpole MA 02032
• Manufacturer Contact: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 5086604381
• MDR Report Key: 4009291
• MDR Text Key: 4707246
• Report Number: 1219913-2014-00205
• Device Sequence Number: 1
• Product Code: MZO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P030056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 07/25/2014

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: 02/05/2015
• Device Model Number: N/A
• Device Catalogue Number: 03438099
• Device Lot Number: 062246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2014
• Initial Date FDA Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1