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

Model Number DIMENSION EXL WITH LM

Device Problem Mechanical Problem (1384)

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

Event Date 04/20/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.The cse changed the sample drain, two sample pump valves and the vessel handling.The cause of the discordant, falsely elevated tacrolimus result is unknown.No further issues were found since the cse had visited the customer.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely elevated tacrolimus result was obtained on a patient sample on a dimension exl with lm instrument.The discordant result was not reported to the physician(s).The initial result was obtained without dilution.The sample was repeated with dilution (1:2) on the same instrument, resulting lower.The customer reran the sample again without dilution resulting lower than the initial result.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated tacrolimus results.

• Brand Name: DIMENSION EXL WITH LM
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; brookfield CT 06804
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 5665346
• MDR Text Key: 45478352
• Report Number: 1226181-2016-00291
• Device Sequence Number: 0
• Product Code: MLM
• Reporter Country Code: IT
• PMA/PMN Number: K130276
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2016
• 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: 04/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/09/2010
• 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