MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) ASSAY; 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 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant ahbs2 results is unknown.Siemens healthcare diagnostics is investigating.Mdr 1219913-2019-00005 was filed for the same event (same customer different site).

Event Description

(b)(6) advia centaur xpt anti-hbs2 (ahbs2) results were obtained for two samples from different patients when comparing reagent lot 098 and reagent lot 102.The results from reagent lot 098 were reported prior to the study with reagent lot 102.The results from lot 098 were recalled and replaced with the (b)(6) results from lot 102.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the anti-hbs2 results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00010 on january 23, 2019.02/01/2019 additional information: the customer had high recovery with bio-rad virotrol ii quality control lot 123590 and patient samples when using advia centaur xpt anti-hbs2 (ahb2) lot 098.When the customer switched to the advia centaur xpt anti-hbs2 (ahb2) lot 102, the quality control and patient samples recovered acceptably.Siemens does not have any claims on how bio-rad virotrol ii controls recover lot to lot so the shift in recovery is not a product issue.Internal data and field data from other customers does not show the same bias between the advia centaur xpt anti-hbs2 lot 098 and lot 102 with patient samples that the customer observed.The customer does not know whether the advia centaur xpt anti-hbs2 lot 098 kits that they used were from the same shipment.The root cause of the high recovery the customer observed with the advia centaur xpt anti-hbs2 lot 098 cannot be determined.Siemens cannot rule out a shipping/handling issue with the reagents.Based on the available information advia centaur xpt anti-hbs2 lot 098 is performing as intended.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2019-00005 supplemental report 1 was filed for the same event (same customer different site).

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00109 on june 4, 2019 and the supplemental report on (b)(6)2019.(b)(6)2019- additional information: as previously reported in mdr 1219913-2019-00109 supplemental 1, siemens' has completed the investigation into an alleged elevated afp value that was reproducibly obtained on the advia centaur xp.Siemens obtained the sample and ran the sample with two separate lots of afp including lot 203 and lot 214.The patient resulted 101 ng/ml on lot 203 and 101 on lot 214.The sample was then treated with a nabt tube but the signal was not reduced therefore the presence of non specific antibodies could not be confirmed.As the patient is on the contraceptive mirena it is less likely they are pregnant therefore the patient is most likely being tested as a potential oncology patient.Siemens' provided this information to the customer and requested additional information regarding the medical status of the patient.No additional information has been received.At this time there has been no product non conformance identified and no data supplied indicating performance issues outside this patient result.No further action is required.Mdr 1219913-2019-00096 and 1219913-2019-00096 supplemental report 1 and 1219913-2019-00096 supplemental 2 were also filed for this event.

• Brand Name: ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) ASSAY
• Type of Device: AHBS2 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 8270826
• MDR Text Key: 133864777
• Report Number: 1219913-2019-00010
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414561790
• UDI-Public: 00630414561790
• Combination Product (y/n): N
• PMA/PMN Number: P100039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2019

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: 07/26/2020
• Device Model Number: N/A
• Device Catalogue Number: 10286268
• Device Lot Number: 66166098
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/23/2019
• Supplement Dates Manufacturer Received: 02/01/2019; 08/02/2019
• Supplement Dates FDA Received: 02/14/2019; 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1