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 01/03/2020

Event Type  malfunction  

Manufacturer Narrative

The calibration was performed but the quality control was not run for the advia centaur xp hcv assay.The cause for the discordant hcv 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 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 1219913-2020-00037 (january 22nd) and mdr 1219913-2020-00038 (january 24th) were filed for the same event.

Event Description

A (b)(6) advia centaur xp hcv (ahcv) result was obtained for a patient sample.On january 22nd, the hcv-rna testing was performed and the result was (b)(6).The patient sample was tested again on the same advia centaur xp system and the result was (b)(6).The patient sample was tested on an alternate method on the same day at a different location.The results were (b)(6).On january 23rd, the patient sample was tested at another laboratory and the result was (b)(6) on the alternate method.On january 24th, the patient sample was tested at another laboratory on the advia centaur xp.The hcv result was (b)(6).The initial results were reported to the physician.It is unknown if the results were questioned.Patient treatment was not altered or prescribed.There was no report of adverse health consequences due to the discordant advia centaur xp hcv result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2020-00036 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 1219913-2020-00037 supplemental report 1 and 1219913-2020-00038 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
• MDR Report Key: 9695492
• MDR Text Key: 195560355
• Report Number: 1219913-2020-00036
• 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

• 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
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 03/10/2020
• Supplement Dates FDA Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1