MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL WITH LM; CLINICAL CHEMISTRY ANALYZER

Model Number DIMENSION EXL WITH LM

Device Problems False Device Output (1226); Incorrect Or Inadequate Test Results (2456)

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

Event Date 05/16/2014

Event Type  malfunction  

Event Description

Discordant, falsely low sodium (na) and chloride (cl) results were obtained on one patient sample on a dimension exl with lm instrument.The discordant results were not reported to the physician(s).The sample was repeated on the same instrument, resulting higher.The corrected results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant, falsely low na and cl results.

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.After evaluation of the instrument and instrument data, the cse recommended that the customer take their centrifuge offline and use their large centrifuge exclusively.It was discovered that the customer was centrifuging patient samples outside of the tube manufacturer specifications (stat spin).Upon follow-up with the customer, no other issues were seen on the instrument since switching centrifuges.The cause of the discordant, falsely low na and cl results is unknown.The cause of the sample being centrifuged outside of tube vendor specifications is failure to follow instructions.The instrument is performing according to specifications.No further evaluation of the device is required.

• Brand Name: DIMENSION EXL WITH LM
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; brookfield CT 06804
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 3864217
• MDR Text Key: 4567442
• Report Number: 1226181-2014-00314
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION EXL WITH LM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/24/2012
• 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