MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION XPAND PLUS WITH HM; CLINICAL CHEMISTRY ANALYZER

Model Number DIMENSION XPAND PLUS WITH HM

Device Problem Mechanical Problem (1384)

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

Event Date 04/15/2016

Event Type  malfunction  

Manufacturer Narrative

A siemens customer service engineer (cse) was dispatched to the customer site.The cse replaced the sample arm.A siemens headquarter support center (hsc) evaluated the instrument data.Low values on read 3, a measure of the absorbance of hemoglobin before the tacrolimus reaction takes place, are suggestive of lower hemoglobin in the sample which was transferred from the sample cup.Low hemoglobin can occur by short sampling: air bubble in the cup, fluidics issues: transfer of sample from a primary tube within which the red cells have begun to settle.Sample handling would account for an air bubble in the sample container or the poor mixing of the primary tube.Aspiration of the aliquot from high or low in the sample column will have less red cells or elevated red cells respectively.The cause of the discordant, falsely low tacrolimus results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

Discordant, falsely low tacrolimus results were obtained on patient samples on a dimension xpand plus with hm instrument.The initial results were not reported to the physician.The samples were repeated on the same instrument, resulting higher.The repeat results were reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely low tacrolimus results.

• Brand Name: DIMENSION XPAND PLUS WITH HM
• 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 INC; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 5653875
• MDR Text Key: 45163242
• Report Number: 1226181-2016-00273
• Device Sequence Number: 0
• Product Code: MLM
• Reporter Country Code: SP
• PMA/PMN Number: K112999
• 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: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION XPAND PLUS WITH HM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2004
• 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