MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP 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 03/27/2019

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant (b)(6) results is unknown.Siemens healthcare diagnostics is investigating.

Event Description

A false reactive advia centaur cp (b)(6) result was obtained for a patient sample.The sample was repeated since the (b)(6) result was reactive.The (b)(6)was reactive.The patient sample was sent out to another branch using the advia centaur xp and tested for (b)(6).The (b)(6) results were nonreactive and the (b)(6) results were reactive.The customer reported (b)(6) result as nonreactive.It is unknown if patient treatment was prescribed or altered.There was no report of adverse health consequences due to the (b)(6) results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00146 on august 1, 2019.08/07/2019 additional information: patient treatment was not prescribed or altered.The type of blood collection tube that was used was serum, bd vaccutainer.Siemens is awaiting further information from the customer.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00146 on (b)(6) 2019.Siemens filed the mdr 1219913-2019-00146 supplemental report 1 on (b)(6) 2019.(b)(6)2019 additional information: siemens has requested the advia centaur xp ahbs2 lot number that was used to test the sample at the pathlab singapore from the customer.The response received was no lot information was provided.(b)(6)2019 additional information: the customer had a sample that recovered repeat reactive (22.64, 21.23 miu/ml) with advia centaur cp anti-hbs2 (ahbs2) lot 102 but was nonreactive when tested with an advia centaur xp at another lab.The sample was hbsag reactive at the customer's lab and the other lab.They believe the nonreactive ahbs2 result.The customer was not able to provide the patient's medical status or a list of medications/supplements the patient is taking.There is no sample that can be sent to siemens for evaluation.The relative sensitivity and specificity section of the advia centaur cp anti-hbs2 instructions for use (ifu) (10629924, revision j, 2017-12) 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.This one false positive result does not indicate a product problem with advia centaur cp ahbs2 lot 102.The cause of the false positive results seen by the customer with this one sample when using advia centaur cp ahbs2 lot 102 could not be determined but siemens cannot rule out pre-analytical factors, a sample issue, or normal assay performance.Based on the investigation, no product problem was identified.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR CP 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: 8850217
• MDR Text Key: 152941142
• Report Number: 1219913-2019-00146
• 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: 09/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2020
• Device Model Number: N/A
• Device Catalogue Number: 10286268
• Device Lot Number: 102
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1