MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM TOTAL HCG (THCG)

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

Samples are received refrigerated up to 4 days refrigerated (2 and 8 ° c) and centrifugation at 3,000 rpm for a period of 15 minutes.The cause for the discordant total hcg results is unknown.Siemens healthcare diagnostics is investigating.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the ifu states in the limitations section: "all in vitro assays can generate erroneous results, both clinically false positive results (test results suggesting a condition that is absent) and clinically false negative results (test results failing to identify a condition that is present).".

Event Description

A false low atellica im total hcg (thcg) result was obtained on a patient sample.The patient sample was repeated and the result was higher.The patient sample was repeated on the second atellica im analyzer and the result was higher and consistent with the first repeat result.The correct result was released to the patient.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant total hcg result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2020-00002 on january 06, 2020.Siemens filed the mdr 1219913-2020-00002 supplemental report 1 on january 30, 2020.February 07, 2020 additional information: the customer reported a discordant patient results on atellica im 1600 s/n (b)(6) for total hcg on 18-dec-2019.The first aspiration for sid (b)(6) occurred at 02:55:25.846 and resulted with 2.2 miu/ml.The sample was from a male patient and lab protocol has all male samples being repeated.The sample was repeated on the same system and aspirated at 05:03:43.538 with a result of 12.6 miu/ml.The higher results was considered as accurate based on the patient's clinical status.The log files were reviewed for atellica im 1600 s/n (b)(6) and they showed that both samples successfully aspirated, processed and resulted without any irregularities or associated errors.Based on the log review, siemens cannot definitively determine the cause of this discordant result.Contributing factors such as sample handling cannot be ruled out due to sample integrity high pressure errors viewed on aspirations prior to sid (b)(6).Quality control was in range and no issues were noted with other patient samples indicating that the instrument and reagents were performing acceptably.Repeat of the same sample on atellica im 1600 s/n (b)(6) yielded expected results.Based on the results of the investigation, return of the patient sample is not warranted.The atellica im total hcg instructions for use (ifu) states that the "this kit is not intended for any use other than assessment of pregnancy status.", anything other than this would be considered an off-label application.A potential product issue has not been identified.The instrument is performing within specifications.No further evaluation of the device is required.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2020-00002 on january 06, 2020.January 10, 2020 additional information: the customer provided the reagent lot number used for sample testing.Lot # 16093311, expiration date: 31-03-2020.Section d4 has been completed with the lot number and expiration date.(b)(6) 2020: the patient is not pregnant.The sample is from a male patient.There was an error transcribing the complaint as female.It is the laboratory's protocol to repeat all thcg results from male patients.Thus, the initial result of 2.2 was repeated and the result of 12.3 and 13.5 were found.Siemens healthcare diagnostics is awaiting further information.The ifu states in the intended use section: "the atellica® im total hcg (thcg) assay is for in vitro diagnostic use in the quantitative determination of human chorionic gonadotropin (hcg) in human serum using the atellica® im analyzer.The results obtained from hcg specimens are used as an aid in the assessment of pregnancy status.This assay detects the intact hcg molecule and free beta-subunits of the hcg molecule." the ifu states in the limitations section: "this kit is not intended for any use other than assessment of pregnancy status.".

• Brand Name: ATELLICA IM TOTAL HCG (THCG)
• Type of Device: TOTAL HCG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 9555673
• MDR Text Key: 193617999
• Report Number: 1219913-2020-00002
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414600031
• UDI-Public: 00630414600031
• Combination Product (y/n): N
• PMA/PMN Number: K172322
• 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: 02/07/2020

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: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 10995690
• Device Lot Number: 16093311
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 01/10/2020; 02/07/2020
• Supplement Dates FDA Received: 01/30/2020; 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 34 YR