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 05/20/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc) to report the discordant sodium result.A siemens customer service engineer (cse) was dispatched to the customer site.The cse ran quality control (qc), and result was in range.The cse ran precision testing for verification.The cse contacted regional support center (rsc) and pulled data.A siemens headquarters support center (hsc) specialist reviewed instrument data files, which indicated that the customer changed standard a (stda) solution right before samples were processed.Qc was run right after samples were processed and resulted low compared to qc that was run prior, indicating the stda bag was low and may have not been rolled enough and the correct amount of stda was not delivered.The presence of air in lines and the primes done when changing the stda bag was not enough to remove air from the tubing.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 low sodium (na) result was obtained on one patient sample on a dimension exl with lm instrument.The discordant result was reported to the physician(s), who questioned it.The original sample was repeated on an alternate instrument, and recovered higher.The corrected result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant na result.

Manufacturer Narrative

The initial mdr 2517506-2017-00549 was filed on jun 29, 2017.Corrected information (07/17/2017): after investigation, the cause of the discordant lytes issue is related to sample handling and not instrument performance.Integrated multisensor technology (imt) data, quality control (qc), and precisions were all normal.Customer is monitoring patient samples and repeating any abnormal results.

• 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: margarita karan ; 511 benedict ave; tarrytown, NY 10590 ; 9145243105
• MDR Report Key: 6677065
• MDR Text Key: 78698397
• Report Number: 2517506-2017-00549
• 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,Followup
• Report Date: 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• 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: 07/17/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2012
• 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