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 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was not dispatched as all quality control (qc) was in range.No instrument errors were observed.The sample tubes are bd vaccutainer tube.Serum samples clot for 30 minutes minimum.The samples are centrifuged before they are initially tested, at 3000 rpm for 10 mins in a bucket (swing out) configuration.The samples were initially aspirated from a blood draw tube.The cause for the discordant (b)(6) results is unknown.The instrument is performing within specifications.No further evaluation of the device is required.The ifu states in the interpretation of results section: "results should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings.The advia centaur anti-hbs2 assay is traceable to the world health organization (who) hepatitis b immunoglobulin 1st international reference preparation (1977).Samples with a calculated value of 10 miu/ml or greater are considered reactive (protective) in accordance with the cdc guidelines.5 the accepted criteria for immunity to hbv is anti-hbs activity >/=10 miu/ml, as defined by the who international reference preparation.Nonreactive: samples with an initial value < 8 miu/ml.Anti-hbs is below 10 miu/ml and the patient is considered not to have protective immunity to hbv infection.Reactive: samples with an initial value >/=12 miu/ml.Anti-hbs is detected at >/=10 miu/ml and the patient is considered to have protective immunity to hbv infection.Retest zone: samples with an initial value >/= 8 and < 12 miu/ml.If results are within the retest zone after initial testing, samples must be retested in duplicate.After retesting, if 3 results are available and 2 results are>/= 10 miu/ml, then the sample is considered to be reactive.If 3 results are available and 2 results are < 10 miu/ml, then the sample is considered to be nonreactive.

Event Description

A (b)(6) advia centaur xp anti-hbs2 (ahbs2) result was obtained for a patient sample.The initial result for the sample was in the retest zone.The sample was repeated in duplicate.One result was (b)(6) and the second result was (b)(6) with the final interpretation as (b)(6).A second sample for the same patient was run.One result was in the retest zone and one result was (b)(6).The (b)(6) result was reported.Another edta plasma tube was tested and the result was (b)(6).The laboratory received another draw for the same patient two weeks later.The sample was tested for (b)(6) and the result was (b)(6).Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the (b)(6) results.

Manufacturer Narrative

Siemens filed the initial mdr on (b)(6) 2019.05/10/2019 additional information: the customer has not had any more instances of nonreactive samples recovering > 10 miu/ml with ahbs2 lot 098.The customer had a serum sample from a patient that recovered reactive (10.42, 4.74, 13.73 miu/ml) with advia centaur xp anti-hbs2 lot 098 but an ethylenediaminetetraacetic acid (edta) plasma from the same patient was nonreactive (3.41 miu/ml).The serum sample was also hbsii nonreactive, hbct nonreactive, and havt nonreactive.A second serum sample from the patient that was part of the same draw recovered 10.1 and 6.47 miu/ml but since the retest zone algorithm in the advia centaur xp/xpt anti-hbs2 instructions for use (ifu) (10698735 revision j, 2016-09) was not followed an interpretation cannot be determined.A new sample from the patient drawn two weeks later recovered nonreactive with the advia centaur xp anti-hbs2 assay.The customer's blood draw tube handling is in alignment with manufacturer's recommendations.The comparison of results section of the advia centaur xp/xpt anti-hbs2 instructions for use (ifu) (10698735 revision j, 2016-09) lists the 95% confidence interval (ci) for negative percent agreement as 96.7% - 98.5%.Given the customer has only had an issue with samples from this one patient there is no indication advia centaur xp ahbs2 lot 098 is failing to meet the negative percent agreement claim in the ifu.The cause of the intermittent elevated results with serum samples from this one draw when using advia centaur xp anti-hbs2 lot 098 could not be determined but pre-analytical factors or a sample issue cannot be ruled out.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 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: 8531708
• MDR Text Key: 158859071
• Report Number: 1219913-2019-00067
• 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: 05/17/2019

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: 10698706
• Device Lot Number: 74240098
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2019
• Initial Date FDA Received: 04/19/2019
• Supplement Dates Manufacturer Received: 05/10/2019
• Supplement Dates FDA Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR