MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. IMMULITE 2000

Model Number IMMULITE 2000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/11/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens headquarters support center (hsc) specialist reviewed the adjustment and quality control data provided by the customer and determined that the adjustments and quality control recoveries were in range.The cause of the discordant thyroglobulin results is unknown.Siemens is investigating the issue.

Event Description

Discordant thyroglobulin results were obtained on three patient samples on an immulite 2000 instrument, while using reagent lot 338.The initial and repeat results were obtained on the same instrument with the same reagent lot.It is unknown if any of the results were reported to physician(s).There are no known reports of patient intervention due to the discordant thyroglobulin results.There are no known reports of a delay in administering treatment or medical intervention to patients due to the discordant thyroglobulin results.

Manufacturer Narrative

The initial mdr 2247117-2017-00033 was filed on march 16th 2017.Additional information (04/24/2017): a siemens headquarter support center (hsc) specialist reviewed the instrument logs, adjustment data and quality control data associated with the discordant results of the three patient samples.There was no indication of an issue with the adjustment of the thyroglobulin (tg) assay.Data review of the instrument support files did not indicate any mechanical factors that could have contributed to the discordant results.With respect to the quality control data associated with each of the discordant results: (b)(6) - discordant result generated on (b)(6) 2016.Review of quality control (qc) data for (b)(6) 2016 indicates that qc was performed with level 1 and was in range.(b)(6) - discordant result generated on (b)(6) 2016.Review of qc data for (b)(6) 2016 indicates that qc was performed with levels 1 and 2 and both levels were high out of range with no repeats observed.(b)(6) - discordant result generated on (b)(6) 2016.Review of qc data indicates that qc was performed with levels 1 and 3 and level 3 was high out of range with no repeats observed.Review of the results of a precision study performed by the customer with thyroglobulin reagent lot 346 indicates that the assay precision with this current reagent lot is within specifications.The cause of the discordant thyroglobulin results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Manufacturer Narrative

The initial mdr 2247117-2017-00033 was filed on march 16th 2017.A follow up mdr 2247117-2017-00033_s1 was filed on may 12th 2017.Additional information (06/13/2017): a siemens customer service engineer (cse) checked the system and performed the annual preventative maintenance (pm).There was no evidence of bubbles in the substrate line and the substrate pump was functioning properly.The seals of the dual resolution diluters (drds) were replaced and the positions of all drds were verified.The tube index sensor on the instrument was replaced with a new one.Distilled water bottle, wash solution bottle and substrate bottle were replaced and all tubings were replaced.An additional precision study was carried out by the customer and a cv of 13.9% was obtained for quality control (qc) level-1.A siemens headquarter support center (hsc) specialist reviewed the data and stated that the maximum % cv allowed at that level is 42.5% as per vericheck.The vericheck program is used for performance verification studies as part of the installation of a new instrument, or the addition of a new assay to an existing instrument.The purpose of these studies is to document that the performance of the specific instrument/ assay being installed is consistent with product claims as stated in the manufacturer's product labeling (instructions for use or ifu).Moreover, these studies can assist the laboratory in compliance with clinical laboratory regulations and accreditation requirements.It is important to note that the studies performed are designed to verify that the observed performance is consistent with claimed performance, rather than to establish performance characteristics.The precision obtained by the customer at the low end of the assay is acceptable.The immulite 2000 thyroglobulin assay ifu has no precision claims for samples below 10 ng/ml.Additional information (07/05/2017): a siemens hsc specialist stated that since the results of the precision study with the quality control materials were acceptable, the discordant results may have been caused due to pre-analytical factors such as clotting time, centrifugation speed, centrifugation time etc.The cause of the discordant thyroglobulin results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Manufacturer Narrative

Additional information (09/28/2017): a siemens technical applications specialist (tas) followed up with the customer and stated that the customer sees one or two discordant results a month.Additional information (10/18/2017): a siemens technical applications specialist (tas) stated that the customer runs 120 thyroglobulin tests per month.Additional information (10/19/2017): a siemens headquarter support center (hsc) specialist reviewed the information and stated that the customer is seeing 1/120 tests (0.8%) or 2/120 tests (1.7%) discordant results per month.As with any machine or system there will be some defect rate which may cause the system or machine to give unacceptable results.Based on the precision study on controls, the assay is performing acceptably for precision.Potential causes for obtaining discordant results on this assay are improper sample handling or sample preparation.Additional information (10/23/2017): a siemens headquarter support center (hsc) specialist received feedback that the system was checked by a siemens regional support center (rsc) engineer and a siemens customer service engineer (cse) and found to be performing according to specifications.The cause of the discordant thyroglobulin results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: IMMULITE 2000
• Type of Device: IMMULITE 2000
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley rd.; flanders NJ 07836
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 62 flanders bartley road; flanders NJ 07836
• Manufacturer Contact: devyani chaudhuri ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242637
• MDR Report Key: 6409456
• MDR Text Key: 70418343
• Report Number: 2247117-2017-00033
• Device Sequence Number: 1
• Product Code: MSW
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K982468
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IMMULITE 2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2017
• 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: Reuse
• Patient Sequence Number: 1