MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XPT HEPATITIS C (AHCV); HEPATITIS C (AHCV) IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report discordant, (b)(6) advia centaur xpt hepatitis c (ahcv) patient results.Quality control (qc) was acceptable at the time of the event.A siemens customer service engineer (cse) was sent to the customer site and performed a yearly maintenance, replaced pinch valves and resuspend syringe.Siemens is investigating.The instruction for use (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 hcv assay is used in conjunction with other manufacturers' assays for specific (b)(6) serological markers." mdr 1219913-2020-00593, and mdr 1219913-2020-00594 were filed for the same event.
Event or Problem Description
(b)(6) advia centaur xpt hepatitis c (ahcv) results were obtained from the same patient and reported to the physician(s).The (b)(6) results are considered discordant compared to a (b)(6) alternate (b)(6) test method.The customer performed initial (b)(6) testing of the same sample on an advia centaur xp, resulting (b)(6).There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant(s), (b)(6) advia centaur xpt hepatitis c (ahcv) results.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2020-00595 initial report on 03-dec-2020 for a false nonreactive advia centaur xp hepatitis c (ahcv) result.23-nov-2020 - correction (d8): siemens was informed that this device was not serviced by a third party.23-nov-2020 - additional information: the ahcv testing performed on the advia centaur xpt system (mdr 1219913-2020-00595) was part of troubleshooting.The false negative ahcv result was not reported to the provider(s).Siemens is investigating.Mdr 1219913-2020-00593 supplemental report 1 and mdr 1219913-2020-00594 supplemental report 1 were filed for the same event.
Additional Manufacturer Narrative
Siemens filed mdr 1219913-2020-00595 initial report on 03-dec-2020 for a false nonreactive advia centaur xp hepatitis c (ahcv) result.Mdr 1219913-2020-00595 supplemental report 1 was filed on 21-dec-2020 for a correction and additional information.On 04-jan-2021 - additional information: siemens has completed the investigation.The hepatitis c virus (ahcv) testing performed on the patient was due to an accidental needle stick with no known history of a hcv infection.Internal data was reviewed for ahcv reagent lot 379 and all medical decision pools, quality control and patient panels resulted as expected.The customer sent out the patient sample to an alternate laboratory for additional testing and the results were negative on another ahcv antibody test and pcr.Based on the additional alternate laboratory testing information, it appears this is not a case of a false negative ahcv with the advia centaur xp assay.Siemens suspects that the initial positive viral load result was potentially incorrect.The customer will investigate separately the viral load alternate hcv test method positive result initially reported.The customer is operational and has not observed any further ahcv issues.A product nonconformance was not identified.The assay is performing within specifications.No further evaluation of the device is required.In section h6, the investigation finding, and investigation conclusion codes were updated.Mdr 1219913-2020-00593 supplemental report 2 and mdr 1219913-2020-00594 supplemental report 2 were filed for the same event.

• Brand Name: ADVIA CENTAUR XPT HEPATITIS C (AHCV)
• Common Device Name: HEPATITIS C (AHCV) IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 10946319
• Report Number: 1219913-2020-00595
• Device Sequence Number: 3210901
• Product Code: MZO
• UDI-Device Identifier: 00630414473161
• UDI-Public: 00630414473161
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/26/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/27/2021
• Device Model Number: N/A
• Device Catalogue Number: 10309061
• Device Lot Number: 379
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 11/23/2020; 01/04/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 12/21/2020; 01/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR