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

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 02/06/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) to report discordant, (b)(6) advia centaur xp anti-hbs2 (ahbs2) results from the same patient.The customer was not able to provide a list of medications/supplements the patient is taking, and there is no sample that can be sent to siemens for evaluation.The clinical sensitivity and specificity section of the advia centaur xp/xpt anti-hbs2 instructions for use (ifu) (10629819, revision l, 2019-08) lists the 95% confidence interval (ci) for resolved relative specificity as 98.34% - 99.88% so a certain number of false positive results can be expected for this assay.The cause of the discrepant results observed by the customer with samples from this one patient when using advia centaur xp ahbs2 reagent lot 122 could not be determined, however pre-analytical factors, a sample issue, or normal assay performance cannot be ruled out.Based on the investigation, no product problem was identified.Incident investigation conclusion is pending customer support feedback.Mdr 1219913-2020-00064 (03-feb-2020), mdr 1219913-2020-00065 (04-feb-2020), and mdr 1219913-2020-00066 (05-feb-2020) were filed for the same patient and event.

Event Description

(b)(6) advia centaur xp anti-hbs2 (ahbs2) results were obtained by the customer on the same patient and considered discordant compared to a negative alternate anti-hbs test method result.The (b)(6) alternate anti-hbs test method result was reported to the physician(s) as the correct result.There are no reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur xp anti-hbs2 (ahbs2) results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2020-00074 report on 24-feb-2020.12-mar-2020 - additional information: siemens has reviewed the event data and has concluded the incident investigation.Customer support feedback regarding the incident investigation was deemed acceptable.In summary, the cause of the discrepant results observed by the customer with samples from this one patient when using advia centaur xp ahbs2 reagent lot 122 could not be determined, however pre-analytical factors, a sample issue, or normal assay performance cannot be ruled out.Based on the investigation, no product problem was identified.The assay is performing within specification.No further evaluation of the device is required.Section h6 conclusion code was updated to reflect the additional information.Mdr 1219913-2020-00064 supplemental report 1, mdr 1219913-2020-00065 supplemental report 1, and mdr 1219913-2020-00066 supplemental report 1 were filed for the same event.

• Brand Name: ADVIA CENTAUR XP ANTI-HBS2 (AHBS2) ASSAY
• Type of Device: AHBS IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9747055
• MDR Text Key: 224634052
• Report Number: 1219913-2020-00074
• 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
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 10286268
• Device Lot Number: 122
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 23 YR