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 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reports observing an increase in atellica im 1600 total hcg (thcg) results within the values of 2-6 (from 4% to 27%), and a decrease in results with values of <2 (from 56% to 35%) in comparison to the advia centaur results.The customer states that they do tracing in patients with testicular cancer and choriocarcinoma.Neither the advia centaur or atellica im total hcg assays are validated for use as a tumor marker.These assays are intended to be used as an aid in the assessment of pregnancy status.The atellica im thcg assay uses the same reagent formulation as the advia centaur.The comparison between the atellica im and advia centaur was determined during validation.The instrument is performing within specifications.No further evaluation of the device is required.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).This kit is not intended for any use other than assessment of pregnancy status.".

Event Description

Discordant high atellica im total hcg (thcg) results were obtained on samples from three patients when compared to the advia centaur platform.The customer compares thcg results obtained previously with the advia centaur to the current atellica im platform results.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant total hcg result.

• 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
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 333 coney street; e. walpole MA 02032
• Manufacturer Contact: eiman sulieman ; 333 coney street; e. walpole, MA 02032 ; 5086604603
• MDR Report Key: 8817526
• MDR Text Key: 151928348
• Report Number: 1219913-2019-00140
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414600031
• UDI-Public: 00630414600031
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K172322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/16/2019
• Device Model Number: N/A
• Device Catalogue Number: 10995689
• Device Lot Number: 31820306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1