MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA IM TOTAL HCG (THCG); VISUAL, PREGNANCY HCG, PRESCRIPTION USE

Model Number N/A

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2023

Event Type  malfunction  

Manufacturer Narrative

A customer from outside of the u.S.Reported observation of an elevated atellica im total hcg (thcg) result for one patient which was discordant relative to repeat testing.An initial result conflicted with lower results produced two days later, using both a new sample and replicate testing of the original sample.The instructions for use (ifu) states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." siemens is investigating.

Event Description

The customer reports observation of an elevated atellica im total hcg (thcg) result for one patient which was discordant relative to repeat testing.The discordant elevated result was observed for an 18-year-old female patient.An initial result conflicted with lower results produced two days later, using both a new sample and replicate testing of the original sample.The initial, discordant result was reported to the physician; the result was not questioned by the physician.There are no allegations of patient harm, changes in treatment, or delays of diagnosis in association with the observed result discordance.

Manufacturer Narrative

Mdr 2432235-2023-00086 was initially submitted on 2023-04-27.Update, 2023 (b)(6): siemens has concluded the investigation.A customer from outside the united states reported observation of an elevated atellica im total hcg (thcg) result for one patient which was discordant relative to repeat testing, using both the original and a new sample.Reagent issues are not indicated as results for external quality control (qc) samples were within expected ranges, and no problems were observed with results for other samples.Instrument performance was assessed, and review of instrument trace files determined that sample and reagent processing met specification, and that there were no signs of issues with aspiration or dispense.Based on the available information, the cause of the discordant result is consistent with preanalytical and/or sample-handling issues.A product problem was not identified.The customer is operational.Note: in section h6, the codes for investigation findings and investigation conclusion have been updated.

• Brand Name: ATELLICA IM TOTAL HCG (THCG)
• Type of Device: VISUAL, PREGNANCY HCG, PRESCRIPTION USE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591 5097
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 333 coney street; east walpole MA 02032
• Manufacturer Contact: barry memishian ; 511 benedict ave.; tarrytown, NY 10591 ; 5082985306
• MDR Report Key: 16830188
• MDR Text Key: 314165866
• Report Number: 2432235-2023-00086
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414600024
• UDI-Public: 00630414600024
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K172322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2023
• Device Model Number: N/A
• Device Catalogue Number: 10995689
• Device Lot Number: 346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2022
• 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
• Patient Age: 18 YR
• Patient Sex: Female