MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (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 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

The samples were stored at -20°c.The quality control (qc) were within +/-1sd for both time frames.The type of blood collection tubes used were bd serum with gel.The samples were allowed to clot for 2 hours.The first centrifugation was at 3420 tr/mn during 11 mn.The samples were recentrifuged and aspirated from a secondary tube for repeat testing.Siemens healthcare diagnostics is investigating.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.".

Event Description

Discordant (b)(6) atellica im anti-hepatitis b surface antigen 2 (ahbs2) results were obtained for samples from two patients.The samples were repeated in the october/november timeframe.The repeat results were (b)(6).The (b)(6) results were reported and questioned by the physician.Corrected reports were issued.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the ahbs2 results.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00258 on (b)(6), 2020.(b)(6), 2020 additional information: the customer is questioning the ahbs2 positive results from july.Siemens is currently evaluating atellica im anti-hbs2 lot to lot variability.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00258 on december 11, 2019.Siemens filed the mdr 1219913-2019-00258 supplemental report 1 on january 28, 2020.February 20, 2020 additional information: the customer provided the summary of results of their study with lot 117.Here is a summary: 87 samples tested previously with lot 117 and with low ahbs2 results (8-15 miu/ml) were tested with lot 125.64/87 (73%) have concordant ahbs2 results with both lots; for 50/64 (78%), ahbs2 result is higher with lot 117 than with lot 125.23/87 (27%) have discrepant ahbs2 results between lot 117 and lot 125; discrepant means that the clinical interpretation is different; 21 samples were positive with lot 117 and are negative with lot 125.From these 23 discrepant samples, 9 gave an ahbs2 result with lot 125 below 3.10 miu/ml when their ahbs2 results with lot 117 were between 8.2 and 14.77 miu/ml the customer believes there is a positive bias with lot 117 of ahbs2.February 21, 2020 additional information: the customer considered the 21 samples that were positive with lot 117 and negative with lot 125 to be false positive with lot 117.Most of the results were reported to physicians last summer.It is unknown if the physicians questioned the results.It is possible that some patients were considered as protected against hepatitis b virus and were not vaccinated.March 5, 2020 additional information: the customer provided the data of their study with lot 117.Siemens is evaluating the data.Siemens continues to evaluate the atellica im anti-hbs2 lot to lot variability.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00258 on december 11, 2019.Siemens filed the mdr 1219913-2019-00258 supplemental report 1 on january 28, 2020.Siemens filed the mdr 1219913-2019-00258 supplemental report 2 on march 16, 2020.Siemens filed the mdr 1219913-2019-00258 supplemental report 3 on april 03, 2020.May 15, 2020 additional information: siemens sourced patients samples from asia, europe, and the united states and while some samples did perform similar to the customer's samples with the atellica im ahbs2 assay, the number of samples does not indicate the atellica im ahbs2 assay is failing to meet the specificity claim in the instructions for use (ifu).A review of smart remote services (srs) field data from europe for atellica im ahbs2 lots showed lot 117 had a similar distribution of nonreactive/reactive results to other lots.The clinical sensitivity and specificity section of the atellica im ahbs2 ifu (10995277, revision 04, 2019-07) 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.A review of internal and field data indicates atellica im ahbs2 lot 117 is performing as intended.The specific cause of the reactive results seen by the customer when using atellica im ahbs2 lot 117 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.Siemens has requested additional information in order to further evaluate the issue.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00258 on december 11, 2019.Siemens filed the mdr 1219913-2019-00258 supplemental report 1 on january 28, 2020.Siemens filed the mdr 1219913-2019-00258 supplemental report 2 on march 16, 2020.March 18, 2020 additional information: the customer provided the data of their study with lot 117.Siemens evaluated the data.The customer retested 87 samples that had previously recovered 8 - 15 miu/ml when tested in the summer of 2019.In the data provided, samples that recovered 8 - 12 miu/ml do not always have 3 replicates, so a final interpretation cannot be determined.Of the 87 samples, a final interpretation of the original and retest results can be determined for 42 of them.Of those 42 samples: the original and retest results for 21 were both reactive.The original and retest results for 9 were both nonreactive.For the other 12, the original results were reactive and the retest results were nonreactive.Of those 12, samples (b)(6) were part of the original complaint.Four of the 12 samples had a retest result of < 3.10 miu/ml.One of the 12 (sample (b)(6)) had a retest result of 1.12 miu/ml, but it is not possible to obtain a value <3.1 miu/ml, so this value is likely a typographical error.One of the samples where the original and retest results were both reactive was (b)(6), part of the original complaint, so this sample was reactive with ahbs2 lots 117 and 125 but nonreactive with lot 113.A review of the quality control (qc) data provided did not show evidence of an issue.Siemens continues to evaluate the atellica im anti-hbs2 lot to lot variability.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2019-00258 on december 11, 2019.Siemens filed the mdr 1219913-2019-00258 supplemental report 1 on january 28, 2020.Siemens filed the mdr 1219913-2019-00258 supplemental report 2 on march 16, 2020.Siemens filed the mdr 1219913-2019-00258 supplemental report 3 on april 03, 2020.Siemens filed the mdr 1219913-2019-00258 supplemental report 4 on june 10, 2020.June 18, 2020 additional information: the customer had samples that when tested in july recovered reactive with atellica im ahbs2 lot 117 but the samples were nonreactive when retested with atellica im ahbs2 lot 113 in november.The customer's blood draw tube handling was in line with manufacturer's recommendations.There was not enough sample to be sent to siemens for evaluation.The customer then retested 87 samples that had previously recovered 8 - 15 miu/ml when tested in the summer of 2019.In the data provided, samples that recovered 8 - 12 miu/ml do not always have 3 replicates so a final interpretation cannot be determined.Of the 87 samples, a final interpretation of the original and retest results can be determined for 42 of them.For 30 of the samples the original and retest results were the same and for 12 of the samples the original results were reactive and the retest results were nonreactive.Siemens sourced patients samples from asia, europe, and the united states and while some samples did perform similar to the customer's samples with the atellica im ahbs2 assay, the number of samples does not indicate the atellica im ahbs2 assay is failing to meet the specificity claim in the instructions for use (ifu).A review of smart remote services (srs) field data from europe for atellica im ahbs2 lots showed lot 117 had a similar distribution of nonreactive/reactive results to other lots.The clinical sensitivity and specificity section of the atellica im ahbs2 ifu (10995277, revision 04, 2019-07) 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.A review of internal and field data indicates atellica im ahbs2 lot 117 is performing as intended.The specific cause of the reactive results seen by the customer when using atellica im ahbs2 lot 117 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.Section h6, the device, method, results and conclusion codes were updated to reflect the additional information.

• Brand Name: ATELLICA IM ANTI-HEPATITIS B SURFACE ANTIGEN 2 (AHBS2)
• Type of Device: AHBS2 IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 9450821
• MDR Text Key: 220567885
• Report Number: 1219913-2019-00258
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414597836
• UDI-Public: 00630414597836
• 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,Followup,Followup
• Report Date: 07/07/2020

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: 09/28/2020
• Device Model Number: N/A
• Device Catalogue Number: 10995453
• Device Lot Number: 66240117
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/11/2019
• Supplement Dates Manufacturer Received: 01/13/2020; 02/20/2020; 03/18/2020; 05/15/2020; 06/18/2020
• Supplement Dates FDA Received: 01/28/2020; 03/16/2020; 04/03/2020; 06/10/2020; 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1