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

Model Number ADVIA CENTAUR XP

Device Problem False Negative Result (1225)

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

Event Date 08/07/2015

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse checked sample probe adjustment and performance, acid and base delivery, and dark counts.The cse did not find an instrument malfunction.The cause of the discordant, false negative hcg result is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, (b)(6) human chorionic gonadotropin (hcg) result was obtained on one patient sample on an advia centaur xp instrument.The discordant result was reported to the physician(s), who questioned it.A new sample was obtained from the patient and tested on the same instrument, resulting (b)(6) and matching the patient's clinical picture.The original sample was then repeated on the same instrument, resulting (b)(6).The corrected result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, (b)(6) hcg result.

• Brand Name: ADVIA CENTAUR XP
• Type of Device: IMMUNOASSAY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict avenue; tarrytown NY 10591
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; manufacturing limited; registration number: 8020888; chapel lane, swords, co., dublin ; EI
• Manufacturer Contact: margarita karan ; 511 benedict avenue; tarrytown 10591 ; 9145243105
• MDR Report Key: 5017968
• MDR Text Key: 24704560
• Report Number: 2432235-2015-00368
• Device Sequence Number: 0
• Product Code: DHA
• Reporter Country Code: GM
• 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: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• 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
• Date Manufacturer Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/03/2011
• 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