MAUDE Adverse Event Report: SIEMENS HEALTHCAR DIAGNOSTICS INC DIMENSION® EXL WITH LM; DIMENSION® EXL WITH LM

Model Number DIMENSION EXL WITH LM

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

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

Event Date 04/04/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The customer reran other patient samples without issues.The customer provided quality control data, which indicated results were within range.There were no system errors observed by the customer.Ccc followed up with the customer the following day and the customer stated the integrated multi-sensor technology module was operational and they did not obtain any discordant results.The cause of the discordant sodium result is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

A discordant, falsely high sodium (na) result was obtained on sample id (b)(6) on a dimension exl with lm instrument.The discordant result was not reported to the physician(s).The original sample was repeated twice on another dimension exl instrument, and recovered lower.The repeat result obtained on the dimension exl was reported to the physician(s).The original sample was also repeated on the original instrument, matching the result obtained on the instrument.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely high na result.

• Brand Name: DIMENSION® EXL WITH LM
• Type of Device: DIMENSION® EXL WITH LM
• Manufacturer (Section D): SIEMENS HEALTHCAR DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration #:1226181; brookfield CT 06804
• Manufacturer Contact: margarit karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6519063
• MDR Text Key: 73617701
• Report Number: 2517506-2017-00443
• Device Sequence Number: 0
• Product Code: JGS
• 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 faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• 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: 04/04/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/02/2009
• 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