MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP; IMMUNOASSAY ANALYZER

Model Number ADVIA CENTAUR XP

Device Problems False Negative Result (1225); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/09/2015

Event Type  malfunction  

Manufacturer Narrative

The cause of the discordant, false negative thcg results is unknown.Siemens healthcare diagnostics is investigating the issue.

Event Description

Discordant, false negative total human chorionic gonadotropin (thcg) results were obtained upon initial and repeat run on one patient sample on an advia centaur xp instrument.The patient initially tested positive using an hcg urine test.The discordant result was reported to the physician(s).The patient was re-tested with hcg urine test, resulting positive.A new sample was obtained from the patient and was tested on the same instrument with the dilution factor as 1:200, resulting positive.The patient was also tested in an alternate laboratory on an unknown methodology, resulting positive.The corrected result from the advia centaur xp instrument was not reported, while it is unknown if the result from the alternate laboratory was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, false negative thcg results.

Manufacturer Narrative

The initial mdr 2432235-2015-00360 was filed on august 14, 2015.Additional information (09/08/2015): a siemens headquarters support center (hsc) specialist reviewed the sample data.The sample data suggested that the initial serum sample was compromised.The customer did not provide the sample for further testing.The customer did not obtain any additional discordant results.The cause of the discordant, false negative thcg results on one patient sample is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords, dublin ; EI
• Manufacturer Contact: michael metz ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242223
• MDR Report Key: 5004703
• MDR Text Key: 25489178
• Report Number: 2432235-2015-00360
• Device Sequence Number: 0
• Product Code: DHA
• Reporter Country Code: FR
• PMA/PMN Number: K971418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ADVIA CENTAUR XP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1