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

Model Number DIMENSION EXL WITH LM

Device Problem Low Test Results (2458)

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

Event Date 05/30/2014

Event Type  malfunction  

Event Description

Discordant, falsely low glucose results were obtained on two patient samples on a dimension exl with lm instrument.The discordant glucose results were reported to the physician(s).The samples were repeated on an alternate system.The corrected results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant glucose results.

Manufacturer Narrative

The siemens customer care center (ccc) was contacted by the customer.The ccc evaluated the instrument data and determined that the customer obtained an instrument absorbance error during the time of the event.The ccc instructed the customer to replace the source lamp.The cause of the discordant glucose results was due to a source lamp malfunction.The instrument is performing within specifications.Further evaluation of the device is not required.

• Brand Name: DIMENSION EXL WITH LM
• Type of Device: CLINICAL CHEMISTRY SYSTEM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; 101 silvermine road; brookfield CT 06804
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC- BROOKFIELD; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: john nelson ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242530
• MDR Report Key: 3895617
• MDR Text Key: 4539027
• Report Number: 1226181-2014-00348
• Device Sequence Number: 1
• Product Code: CGA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• 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
• Device Age: 1 YR
• Date Manufacturer Received: 05/31/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/03/2013
• 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