MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP TSH; THYROID STIMULATING HORMONE IMMUNOASSAY

Model Number N/A

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 11/25/2016

Event Type  malfunction  

Manufacturer Narrative

Customer observed that one readypack of the tsh reagent was discolored compared to other readypacks of the same lot.The customer also noted that the paramagnetic particles were stuck to the top of the readypack and did not go back into solution upon mixing.This was not observed until after the patient results were generated.The customer feels there was a shipping issue with the readypack.The instrument is performing within specification.No further evaluation of the device is required.

Event Description

Customer observed falsely low advia centaur xp tsh results on (b)(6) patients that were elevated upon repeat testing.Customer noted that the falsely low results were all tested from the same readypack of reagents which had paramagnetic particles that did not go into solution upon mixing.The initial results were reported to physicians and corrected reports were sent upon repeat testing.There are no reports that treatment was altered or prescribed or adverse health consequences due to the falsely low advia centaur xp tsh results.

• Brand Name: ADVIA CENTAUR XP TSH
• Type of Device: THYROID STIMULATING HORMONE IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; tarrytown NY 10591
• 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: 6193210
• MDR Text Key: 62998021
• Report Number: 1219913-2016-00248
• Device Sequence Number: 1
• Product Code: JLW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910981
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 12/21/2016

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: 07/22/2017
• Device Model Number: N/A
• Device Catalogue Number: 10309958
• Device Lot Number: 62352273
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/22/2016
• 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