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 04/10/2019

Event Type  malfunction  

Manufacturer Narrative

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 positive atellica im total hcg (thcg) result was obtained on a patient sample.The patient was retested with a different sample, and the result was negative.The initial sample was repeated and the result was negative.A corrected report was issued.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 on may 3, 2019.06/04/2019 additional information: one patient has shown discordant results with two different samples, drawn on different days: (b)(6) was tested on (b)(6) 2019, result was negative (<0.05 miu/ml).(b)(6) was tested on (b)(6) 2019, result was negative (<0.05 miu/ml).(b)(6) was tested on (b)(6) 2019, result was 42 miu/ml.(b)(6) was tested on (b)(6) 2019, result was 3.5 miu/ml.(b)(6) was tested on (b)(6) 2019, result was negative (<0.05 miu/ml).Siemens reviewed the data, there was no service performed on the instrument.In this case the discordant result was due to gaining rlu for a direct assay.There are multiple potential causes for this issue (wash/ aspiration issues or acid/base delivery).The review of the instrument files did not reveal a chronic instrument issue or a product problem.Based on this investigation no product problem was identified.The cause for the discordant total hcg result is unknown.The instrument is operational.No further evaluation of the device is required.

• 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: 8578298
• MDR Text Key: 191285794
• Report Number: 1219913-2019-00072
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414600024
• UDI-Public: 00630414600024
• 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
• Report Date: 06/27/2019

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: 07/25/2019
• Device Model Number: N/A
• Device Catalogue Number: 10995689
• Device Lot Number: 04187304
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/18/2019
• Initial Date FDA Received: 05/03/2019
• Supplement Dates Manufacturer Received: 06/04/2019
• Supplement Dates FDA Received: 06/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR