MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP TOTAL HCG

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/13/2018

Event Type  malfunction  

Manufacturer Narrative

The cause for the discordant total hcg results is unknown.The customer reported a falsely high result on a patient for total hcg when tested on the advia centaur xp.The falsely high result was reproduced when the same sample was run on another advia centaur xp.A second sample drawn at the same time from this patient results negative for total hcg.Quality control and other patient samples are not affected.All other patients are resulting as expected.Possible cause could be either the initial wrong sample was run or there was a preanalytical issue with the sample itself.Possible preanalytical factors include incomplete clotting and the formation of fibrin.The customer continues to run controls and patients for total hcg without further concern.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 patient's medical history, clinical presentation and other findings." mdr 1219913-2018-00076 was filed for the same event.

Event Description

A discordant positive advia centaur xp total hcg result was obtained for a patient sample.Repeat testing was performed on the second advia centaur xp and the result was positive.A second specimen from the same draw was tested on the second advia centaur xp instrument and the result was negative.The discordant results were reported to the physician and questioned.No corrected report was issued.The patient is undergoing acne treatments and taking acutaine.It is unknown if the patient is pregnant or not.It is unknown if patient treatment was prescribed or altered.There was no report of adverse health consequences due to the discordant total hcg result.

• Brand Name: ADVIA CENTAUR XP TOTAL HCG
• 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: 7260730
• MDR Text Key: 99953182
• Report Number: 1219913-2018-00018
• Device Sequence Number: 1
• Product Code: JHI
• UDI-Device Identifier: 00630414505183
• UDI-Public: 00630414505183
• 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: 02/09/2018

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: 05/10/2018
• Device Model Number: N/A
• Device Catalogue Number: 10331723
• Device Lot Number: 06060294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/09/2018
• 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
• Patient Age: 15 YR