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 02/14/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc) specialist.The ccc reviewed the data provided.The ccc found that the customer had their auto-rerun off, preventing the instrument from auto-diluting.The customer configured the auto-dilution feature on and reran the undiluted patient sample, resulting higher and without error flags.A siemens headquarters support center (hsc) reviewed the event.Hsc stated a "high a error" occurs when there is an absorbance error for a very high concentration and it is not a reportable result.The reported result is expected to be much lower than the actual result.A "high a error" flagged result is not a reportable result.The cause of the discordant, flagged human chorionic gonadotropin result being reported out is due to user error.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

A discordant, flagged human chorionic gonadotropin result was obtained on a patient sample on a dimension exl 200 instrument.The initial result was not reported out to the physician(s).The customer repeated the same sample, diluted 1:5, on the same instrument, resulting higher and with a "high a error" flag.The customer repeated the same sample, diluted (1:20) without the dilution factor, resulting higher and with a "high a error" flag.The customer reported out the second repeat result to the physician(s).The customer repeated the same sample on an auto-dilution run (undiluted), resulting higher, without flags.The customer did not send a corrected report for the auto-dilution run, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, flagged human chorionic gonadotropin result being reported out.

• 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 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; registration number: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: timothy rice ; 511 benedict ave; tarrytown, NY 10591 ; 9145242406
• MDR Report Key: 6393528
• MDR Text Key: 69571781
• Report Number: 2517506-2017-00244
• Device Sequence Number: 0
• Product Code: DHA
• 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: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/14/2017
• Initial Date FDA Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/25/2016
• 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