MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR XP FT4; RADIOIMMUNOASSAY, FREE THYROXINE

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 02/19/2017

Event Type  malfunction  

Manufacturer Narrative

The initial result was tested with a different reagent readypack to the repeat result.The patient samples are serum samples and are tested in the primary tube.The sample tubes are gel barrier 8.5 ml biogen tubes (expiration date: 12/2017).The sample tubes are centrifugated for 10 minutes at 3000 rpm.When the samples are re-tested on a different day, the samples are stored capped at 4-8 degrees c.The cause for the discordant ft4 result 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

Discordant advia centaur xp ft4 results were obtained for samples from several patients when repeat testing was performed after recalibration of the assay.The ft4 assay was recalibrated due to quality control (qc) values out of range.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant ft4 result.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2017-00065 on march 28, 2017.On 03/23/2017 additional information: siemens was provided with the water test samples from the customer site.It seems that the water reservoir is contaminated.The customer was asked to replace the water reservoir with a clean one.On (b)(6), the water reservoir was decontaminated and monthly maintenance was performed by the customer.On (b)(6), the ft4 quality controls were run and were below 2sd and 3sd.The ft4 assay calibration was performed on (b)(6) and the quality controls were in range.After recalibrating the ft4 assay on (b)(6), the quality controls were in range.The customer was sent reagent lot 076 for use.Siemens is awaiting for an update when reagent lot 076 is in use by the customer.Siemens continues to investigate.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2017-00065 on march 28, 2017.Siemens filed the mdr 1219913-2017-00065 supplemental report 1 on april 20, 2017.On 06/02/2017 additional information: the performance of ft4 lot 076 was reported to show the same calibration stability as lot 075.The customer has to re-calibrate every 4 to 5 days when controls are out of range high or low.Siemens continues to investigate.

Manufacturer Narrative

Siemens filed the initial mdr 1219913-2017-00065 on march 28, 2017.Siemens filed the mdr 1219913-2017-00065 supplemental report 1 on april 20, 2017.Siemens filed the mdr 1219913-2017-00065 supplemental report 2 on june 19, 2017.07/18/2017 additional information: siemens performed the investigation with a testing protocol that left the ft4 readypacks for lot 075 and 076 on the instrument for seven days and the biorad lyphochek immunoassay plus control (n=1) were run for seven consecutive days without recalibrating.Ft4 reagent lots 075 and 076 with calibrator a lot 91 and biorad controls lot 40310 were used.Advia centaur xp ft4 lot 075, 40311, 40312, 40313; day 1 0.630 1.92 2.85; day 2 0.660 1.78 3.05; day 3 0.680 1.90 3.09; day 4 0.670 1.89 2.90; day 5 0.650 1.88 2.99; day 6 0.680 1.93 2.97; day 7 0.680 1.86 2.86; mean 0.664 1.88 2.96.Advia centaur xp ft4 lot 076, 40311, 40312, 40313; day 1 0.790 1.98 3.26; day 2 0.690 1.83 3.05; day 3 0.640 1.97 3.35; day 4 0.710 1.87 3.09; day 5 0.680 1.91 2.96; day 6 0.690 1.78 3.00; day 7 0.610 1.90 2.97; mean 0.687 1.89 3.10.Advia centaur xp: mean: range: units: 40311 0.735 0.553-0.917 ng/dl; 40312 1.96 1.54-2.37 ng/dl 40313 3.17 2.52-3.83 ng/dl.All control results, on both reagent lots, on every day, were within biorad package insert ranges.Siemens has not confirmed the customer's observation.The cause for the discordant ft4 result is unknown.The instrument is performing within specifications.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR XP FT4
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• 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: 6440582
• MDR Text Key: 71212043
• Report Number: 1219913-2017-00065
• Device Sequence Number: 1
• Product Code: CEC
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K132249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2017
• Device Model Number: N/A
• Device Catalogue Number: 10282219
• Device Lot Number: 70848074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: No
• 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