MAUDE Adverse Event Report: SIEMENS HEALTHCARE 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) to report the discordant sodium(na) result.The customer replaced the integrated multi-sensor technology sensor.The customer ran a diluent check and precision testing, which resulted as expected.The customer ran quality controls (qc) after replacing the sensor, and qc was in range.The siemens customer service engineer (cse) called to the customer and followup regarding issue.Upon follow up, the customer reported that the issue was resolved.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 one patient sample on a dimension exl with lm instrument on (b)(6) 2017.The discordant result was reported to the physician(s).The same sample was repeated on the same instrument and recovered lower.A new sample draw was obtained from the patient and tested on the same instrument, resulting lower and matching the repeat result.A corrected report was not provided to physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant na result.

• Brand Name: DIMENSION® EXL WITH LM
• Type of Device: DIMENSION® EXL WITH LM
• Manufacturer (Section D): SIEMENS HEALTHCARE 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: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6548733
• MDR Text Key: 74667288
• Report Number: 2517506-2017-00472
• 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: 05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• 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: 04/11/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/26/2014
• 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