MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP TOTAL HCG ASSAY; TOTAL HCG IMMUNOASSAY

Model Number N/A

Device Problem No Apparent Adverse Event (3189)

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

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

The patient sample was tested both neat and on-board diluted 1:200.The neat value was within the assay range of 2-1000 miu/ml (iu/l) and the on-board 1:200 dilution recovered above range at 1359 miu/ml (iu/l).The advia centaur cp thcg assay has an over-dilution set-point of 5 miu/ml (iu/l).When this sample was diluted 1:200 it resulted just above this threshold and when the calculation was applied the value was discordant when compared to the neat value.The dilutions section of the advia centaur cp thcg instructions for use states: "serum samples with hcg values greater than 1000 miu/ml (iu/l) must be diluted and retested to obtain an accurate result." this customer runs their thcg samples both neat and diluted and normally reports the neat value when the result is within assay range.This was an isolated event at the laboratory and the thcg assay performance is acceptable.A potential product issue was not identified.Customer is operational.No further investigation is required.

Event Description

Customer observed a patient result on a diluted (1:200) sample using the advia centaur cp total hcg (thcg) assay that was elevated compared to the neat result.There are no reports that treatment was altered or prescribed or adverse health consequences due to elevated advia centaur cp thcg result.

• Brand Name: ADVIA CENTAUR CP TOTAL HCG ASSAY
• Type of Device: TOTAL HCG IMMUNOASSAY
• 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: louise mclaughlin ; 333 coney street; east walpole, MA 02032 ; 5086604381
• MDR Report Key: 9494715
• MDR Text Key: 219764132
• Report Number: 1219913-2019-00278
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414505176
• UDI-Public: 00630414505176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2020
• Device Model Number: N/A
• Device Catalogue Number: 10308985
• Device Lot Number: 63282307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2019
• 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