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

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 02/27/2019

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was sent to the customer site for system inspection.Siemens healthcare diagnostics is investigating.

Event 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.

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)
• Type of Device: AHBS2 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8466283
• MDR Text Key: 146263826
• Report Number: 1219913-2019-00045
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414591407
• UDI-Public: 00630414591407
• Combination Product (y/n): N
• PMA/PMN Number: P100039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2020
• Device Model Number: N/A
• Device Catalogue Number: 10698706
• Device Lot Number: 10979104
• Initial Date Manufacturer Received: 03/06/2019
• Initial Date FDA Received: 03/29/2019
• Supplement Dates Manufacturer Received: 05/10/2019
• Supplement Dates FDA Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1