MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL 200; CLINICAL CHEMISTRY ANALYZER

Model Number DIMENSION EXL 200

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/11/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).The customer stated that the quality controls (qc) were within range on the day of the event.As per ccc specialist's recommendations, the customer reran qc, which were within range and also, ran precision testing on random patient samples, which passed.However, the sample in question gave imprecise results.A siemens headquarters support center (hsc) reviewed the information related to the event and found no sign of an instrument or method related issue on the date of occurrence.The cause of the discordant, falsely depressed glu result on one patient sample is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, falsely depressed glucose (glu) result was obtained on one patient sample on a dimension exl 200 instrument.The discordant result was not reported to the physician(s).The sample was repeated on the same instrument, resulting higher.The customer informed the nurse that the initial result was incorrect.The customer ran a precision study on the patient sample and obtained imprecise results.The customer obtained a new sample from the patient.The redrawn sample was tested, which resulted higher than previously obtained results.There are no reports of patient intervention or adverse health consequences due to the discordant, falsely depressed glu result.

• Brand Name: DIMENSION EXL 200
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC; 500 gbc drive; po box 6101; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC; registration number: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: cassandra kocsis ; 511 benedict avenue; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6298912
• MDR Text Key: 66478719
• Report Number: 2517506-2017-00125
• Device Sequence Number: 0
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073604
• 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: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION EXL 200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/20/2013
• 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