MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM HEPATITIS B SURFACE ANTIGEN II (HBSII) ASSAY; HBSII IMMUNOASSAY

Model Number N/A

Device Problem False Positive Result (1227)

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

Event Date 03/03/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) to report a discordant false reactive (positive) atellica im (b)(6) surface antigen ii ((b)(6)) result obtained on a patient sample.The customer's internal quality control was correct; however, an external quality control was not used at the time of the event.Repeat (b)(6) testing of the original sample was performed one month after initial testing.Siemens is investigating.The instruction for use (ifu) under the limitation section states the following: "for diagnostic purposes, the atellica im (b)(6) test results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings." the instruction for use (ifu) under the specimen collection and handling and storing the specimen states the following: "store primary tube samples at 2-8°c for up to 7 days.Primary tube samples include serum stored on the clot, plasma stored on packed red cells, and samples processed and stored in gel-barrier blood collection tubes.When 10 samples in these primary tubes were tested up to 7 days, no clinically significant differences were observed.Store samples capped and upright at all times at 2-8°c for up to 14 days.Freeze samples, devoid of red blood cells, at less than or equal to -20°c for longer storage.Do not store in a frost-free freezer.When 10 samples were subjected to 6 freeze-thaw cycles, no clinically significant differences were observed.".

Event Description

A false reactive (positive) atellica im (b)(6) surface antigen ii ((b)(6)) result was obtained on a patient sample and reported to the physician(s).The patient was a candidate for an organ transplant that was delayed due to the reactive (b)(6) result.The patient was tested for (b)(6) at two other alternate laboratories and the results were non-reactive (negative).The customer performed repeat atellica im (b)(6) testing on the same patient sample one month later and the results were non-reactive (negative).There are no reports that treatment was altered or prescribed or adverse health consequences due to the delay in organ transplant due to the discordant atellica im (b)(6) result.

Manufacturer Narrative

Mdr 1219913-2020-00099 was filed on 22-apr-2020 for a false reactive (positive) atellica im hepatitis b surface antigen ii (hbsii) patient result.23-apr-2020 - additional information: the patient suffers from nefropatía derived of lupus eritematoso sistémico on terminal state, and the patient (she) has a failed transplantation by contamination with poliomavirus.The physician solicited confirmation for viral load for hepatitis b, antígen e and total core antibody, however the results were not offered.The patient has kidney disease and had a previous organ transplant fail due to a polyomavirus.There is no information indicating the medications the customer was taking would interfere with the atellica im hbsii assay.Medication/supplement list: omeprazole 20mg/day.Prednisolone 5mg/ day.Losartan 50 mg 12 hours.Clonidine 1 tab day.Carvedilol 1 tab day.Tacrolimus.Ketosteril.Calcio + vitamin d 600mg day - calcium and vitamin d supplement.Calcitriol 0.25mcg by day.Sample handling information: the sample was allowed to clot from 7:41 am until 9:30 am and centrifuged at 4000 revolutions per minute (rpm) for 10 minutes.The centrifuge has an oscillating rotor with 40 positions.The initial and retest results were aspirated from a sample cup.The sample was drawn in a tube with gel separator and the customer's blood draw tube procedures are in line with the manufacturer's recommendations.It is possible during the transfer of the sample to a secondary tube something was transferred to the secondary tube that interfered with the atellica im hbsii assay.One of the actual alternate test method result provided.Date: hbsag result: (b)(6) 2020.0.25 s/co (negative).Siemens has reviewed the event data and has concluded the incident investigation.The initial hbsagii result for this patient was > 50 index.The hbsag ii instruction for use (ifu) under the interpretation of results section does not require hbsag confirmatory testing for results > 50 index, and states the following: "reactive: if the sample is > 50.0 index or flagged as "> index range," the specimen is reactive (positive) for hepatitis b surface antigen and no further testing is required." however, the ifu under the limitation section does state the following: "note: when the atellica im hbsii assay is used as a stand-alone assay (for example, in pregnant women being screened to identify neonates who are at risk for acquiring hbv during the perinatal period), it is suggested that the atellica im hbsii conf assay be used to confirm the result." in this event, the patient sample was anti-hepatitis b surface antigen 2 (ahbs2) reactive (34.81 miu/ml).The ifu under the limitation section states the following: "for diagnostic purposes, the atellica im hbsii test results should always be assessed in conjunction with the patient's medical history, clinical examination, and other findings." the cause of the false positive results observed by the customer when using the atellica im hbsii reagent lot 210 is unknown, however pre-analytical factors, a sample issue, or normal assay performance cannot be ruled out.The specificity section of the atellica im hbsii instructions for use (ifu) (10995358, revision 03, 2019-07) lists the 95% confidence interval (ci) for specificity (after retest) as 99.78% - 99.97%.The false positive hbsagii result does not indicate a potential product issue with the atellica im hbsii reagent lot 210.The assay is performing within specification.No further evaluation of the device is required.Section h6 result and conclusion codes were updated to reflect the additional information.

• Brand Name: ATELLICA IM HEPATITIS B SURFACE ANTIGEN II (HBSII) ASSAY
• Type of Device: HBSII IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9985495
• MDR Text Key: 226761519
• Report Number: 1219913-2020-00099
• Device Sequence Number: 1
• Product Code: LOM
• UDI-Device Identifier: 00630414599274
• UDI-Public: 00630414599274
• Combination Product (y/n): N
• PMA/PMN Number: P110041
• 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: 05/15/2020

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: 11/03/2020
• Device Model Number: N/A
• Device Catalogue Number: 10995604
• Device Lot Number: 210
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2020
• Initial Date FDA Received: 04/22/2020
• Supplement Dates Manufacturer Received: 04/23/2020
• Supplement Dates FDA Received: 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1