MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP TOTAL HCG; RADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN

Model Number N/A

Device Problem High Test Results (2457)

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

Event Date 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2021, the customer observed a patient result of 74.8 miu/ml when using advia centaur cp thcg, lot 322.This result was considered inconsistent with past patient results.The sample was repeat-tested using an alternate method, and produced a negative result.The same sample was sent to a reference laboratory for additional testing, but no information was made available regarding that testing result.The instructions for use (ifu) for advia centaur cp thcg states the following, under interpretation of results: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." siemens is investigating.

Event Description

The customer observed an elevated result for one patient when using the advia centaur cp total hcg (thcg) assay which was discordant relative to patient history and repeat-testing by an alternate method.There are no allegations of patient harm or change in treatment as a result of the observed discordance.

Manufacturer Narrative

Mdr 1219913-2021-00178 was filed on 10-mar-2021 to report a discordant elevated patient result observed when using advia centaur cp total hcg (thcg), lot 322.Additional information, 11-mar-2021: siemens has concluded the incident investigation.The customer observed upward drift in qc results for advia centaur cp total hcg (thcg) reagent lot 322 as the reagent pack is used.They indicate that values often exceed their local laboratory limits although they may not exceed the limits expressed for the qc material.The customer reported observation of a discordant positive result for one patient which conflicted with patient history and with the result obtained by an alternate method.Additional troubleshooting investigation by the customer revealed that system fluids (acid and base) on-board the instrument had exceeded their stated on-board stability interval.The operator's guide for the advia centaur cp stated that acid and base reagents can be used until their labeled expiration date, or for 28 consecutive days after initial loading, whichever occurs first.The customer's system is now operational and performing as expected.The customer needs no further assistance.No further evaluation of the device is required.Note: in section h6, the investigation findings and investigation conclusion codes were added.

• Brand Name: ADVIA CENTAUR CP TOTAL HCG
• Type of Device: RADIOIMMUNOASSAY, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 11452321
• MDR Text Key: 268555893
• Report Number: 1219913-2021-00178
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414505176
• UDI-Public: 00630414505176
• Combination Product (y/n): N
• PMA/PMN Number: K925277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2021
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 322
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1