MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR ANTI-HBS2 (AHBS2); AHBS2 IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens customer service engineer (cse) was sent to the customer site for system inspection.Siemens healthcare diagnostics is investigating.
Event or Problem Description
A customer was concerned about (b)(6) results obtained for one patient that was tested using advia centaur xp anti-hbs2 (ahbs2).Clinical history of the patient is unknown.Patient treatment was not prescribed or altered.There is no report of adverse health consequence due to the advia centaur xp results.
Additional Manufacturer Narrative
Siemens filed the initial mdr on march 29, 2019.Additional information - may 10, 2019 and may 16, 2019: siemens customer service engineer (cse) provided a service call and performed the following: checked the advia centaur xp aspiration and dispense of all ports, cleaned the wd and d3 plungers, made probe adjustments to center, cleaned rinse stations and lubricated syringes.No parts were replaced; system fully functional on departure.The customer indicated that the sample was not repeated with the advia centaur xp anti-hbs2 assay and has not provided any information on the patient's medical status or medications.The customer did not provide any information that would indicate that the initial advia centaur xp anti-hbs2 sample result of 237.04 index is incorrect.The customer indicated that the physician did not question the initial advia centaur xp anti-hbs2 results.Medical procedure or treatment, that may later be determined to have been unnecessary, was not performed.The test result did not cause a medical procedure, which may later be determined to have been necessary, to be delayed or withheld.Based on the investigation and information provided by the customer, no product problem was identified.The instrument is performing within specifications.No further investigation or evaluation of the device is required.

• Brand Name: ADVIA CENTAUR ANTI-HBS2 (AHBS2)
• Common Device Name: AHBS2 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8466283
• Report Number: 1219913-2019-00045
• Device Sequence Number: 1341651
• Product Code: LOM
• UDI-Device Identifier: 00630414591407
• UDI-Public: 00630414591407
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P100039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2019

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: 09/26/2020
• Device Model Number: N/A
• Device Catalogue Number: 10698706
• Device Lot Number: 10979104
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 05/10/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1