MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL 200; CLINICAL CHEMISTRY ANALYZER

Model Number DIMENSION EXL 200

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

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

Event Date 03/14/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care (ccc) and stated that the integrated multi-sensor technology (imt) sensors were unstable.The customer replaced the imt sensor and ran conditioning.Quality controls were run, which were within acceptable ranges.Siemens regional support center (rsc) and headquarters support center (hsc) specialists reviewed the instrument data and determined that the customer was using the imt sensor for 7 days, whereas siemens claims the use of the imt sensor is for 5 days.Additionally, the customer was spinning the sample tubes for one minute at the speed of 10,000 rotations per minute.The hsc specialist stated that the customer must follow proper tube manufacturer recommendations for centrifugation times and speed.The hsc specialist also recommended that the customer must review proper pre-analytical sample handling procedures including mixing of the sample after phlebotomy to ensure complete dispersion of the anti-coagulant or clot activator throughout the sample.The rsc specialist determined that the customer's dilution factor was lower than expected.The rsc specialist also determined that the customer was not performing the required troubleshooting such as daily maintenance, which must be followed to ensure accuracy and system performance.The cause of the discordant, falsely elevated k result on one patient sample is unknown.The instrument is performing within manufacturing specifications.No further evaluation of device is required.

Event Description

Discordant, falsely elevated potassium (k) results were obtained on one patient sample on a dimension exl 200 instrument.The discordant results were not reported to the physician(s).The sample was repeated on the same instrument, resulting lower and matching the clinical picture of the patient.The repeat result was reported to the physician(s).There are no known reports of patient intervention or adverse health consequence due to the discordant, falsely elevated k results.

• Brand Name: DIMENSION EXL 200
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration #: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6482265
• MDR Text Key: 72674512
• Report Number: 2517506-2017-00358
• Device Sequence Number: 0
• Product Code: CEM
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K073604
• 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
• Report Date: 04/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION EXL 200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/06/2013
• 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