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 No Apparent Adverse Event (3189)

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

Event Date 01/24/2020

Event Type  malfunction  

Manufacturer Narrative

The calibration was performed but the quality control was not run for the advia centaur xp (b)(6) assay.The cause for the (b)(6) results is unknown.Siemens healthcare diagnostics is investigating.The ifu states in the limitations section: "a (b)(6) 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 (b)(6) assay is used in conjunction with other manufacturers' assays for specific (b)(6) serological markers." mdr 1219913-2020-00039 (january 23rd) was filed for the same event.

Event Description

A (b)(6) advia centaur xp (b)(6) result was obtained for a patient sample.On january 15th the sample arrived at the laboratory for immunoassay and molecular (b)(6) testing.The (b)(6)-rna testing resulted (b)(6).On january 23rd, the sample for (b)(6) testing resulted (b)(6) on the advia centaur xp with lot 339.On january 24th, the patient sample was tested at another laboratory on the advia centaur xp with lot 335 and the (b)(6) result was (b)(6).The patient sample was tested on an alternate method at a different location and the result was (b)(6).Patient treatment was not altered or prescribed.There was no report of adverse health consequences due to the (b)(6) advia centaur xp (b)(6) result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2020-00040 on february 11, 2020.March 10, 2020 additional information: siemens has completed the investigation into the false negative hcv result.There was no quality control (qc) run on the day the samples were run.However, the sample was tested at an alternate lab and lot number and repeated negative.Multiple attempts were made to gather more information to investigate for potential root cause, but no response was received.There has been no further reports of discordant samples from this customer.It is possible that the patient had a very old infection and was recovered or it is possible that this was a case of a false positive result on the alternate method.It had been indicated that pcr was run however no data was submitted.Hcv lot in house data was reviewed and all patient pools, medical decision pool and quality control were resulting as intended.No product non conformance was identified.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2020-00039 supplemental report 1 was 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
• MDR Report Key: 9695504
• MDR Text Key: 213499187
• Report Number: 1219913-2020-00040
• 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: 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2020
• Device Model Number: N/A
• Device Catalogue Number: 10309061
• Device Lot Number: 335
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1