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

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 02/03/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) and stated that they had repeated all the samples run on february 3, 2017 and no additional discordant results were obtained.Quality controls were within acceptable range.Upon the ccc specialist's instructions, the customer performed precision testing on low and high quality controls, which were acceptable.The cause of the discordant, falsely elevated tbi result on one patient sample is unknown.The instrument is performing within specifications.No further evaluation of device is required.

Event Description

A discordant, falsely elevated total bilirubin (tbi) result was obtained on one patient sample on a dimension exl with lm instrument.The discordant result was not reported to the physician(s).The sample was repeated on the same instrument and on an alternate dimension exl instrument, resulting lower each time.The repeat result from the alternate dimension exl instrument was reported to the physician(s).There are no known reports of patient intervention or adverse health consequence due to the discordant, falsely elevated tbi result.

• Brand Name: DIMENSION EXL WITH LM
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration #: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6361024
• MDR Text Key: 68413923
• Report Number: 2517506-2017-00206
• Device Sequence Number: 0
• Product Code: MQM
• 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: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• 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: 02/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/15/2009
• 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