Model Number N/A |
Device Problem
Incorrect Or Inadequate Test Results (2456)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/05/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
The bio-rad quality control was within the normal range and no instrument errors were found with the system during the event.The cause for the discordant ft4 results is unknown.Siemens healthcare diagnostics is investigating.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.".
|
|
Event Description
|
False low advia centaur xp ft4 result was obtained for samples from eight patients during physical examination.The results were considered discordant with ft3 and tsh3-ultra.The patient samples were tested with the advia cenatur xp ft3 and tsh3-ultra and the results supported a euthyroid condition.The results were reported to the physician and were questioned.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant ft4 result.
|
|
Manufacturer Narrative
|
On 01/19/2017 additional information: recall number: 1219913-01/10/2017-002-r.
|
|
Manufacturer Narrative
|
Siemens filed the initial mdr 1219913-2016-00256 on december 21, 2016.On 01/05/2017 additional information: siemens has performed an internal investigation and has confirmed a negative bias for the advia centaur ft4 when used with calibrator a kit lots ending in 90 on the advia centaur, advia centaur xp and advia centaur xpt systems.In addition, siemens healthcare diagnostics confirmed the potential for calibration failures due to above limit calibrator rlu %cvs when using calibrator a kit lots ending in 90 with the ft4 assay.Siemens issued ufsn cc 17-04.A.Ous (january 2017) and umdr cc 17-04.A.Us (january 2017) informing the customer of ft4 assay negative bias observed with calibrator a kit lots ending in 90.Instructions on actions to be taken are provided in the customer communication.
|
|
Search Alerts/Recalls
|