MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM

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 03/24/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens customer care center (ccc).With assistance from the ccc, the customer centered the silver nuts in the reagent probe 1 (r1) and reagent probe 2 (r2), checked the ultrasonics and probes.The customer performed a system check.The check passed.The customer also cleaned the windows and replaced a window that had a cracked frame.After the troubleshooting performed the issue was resolved.The cause of the discordant falsely high hemoglobin a1c result is unknown.The instrument is performing according to specifications.No further evaluation of this device is required.

Event Description

A discordant falsely high hemoglobin a1c result was obtained from a dimension exl with lm instrument.The result was reported to the physician, who questioned the result.The same sample was used for repeat testing on the same dimension exl with lm instrument.The repeat result was reported to the physician.There are no known reports of patient intervention or adverse health consequences due to the discordant falsely high hemoglobin a1c result.

• Brand Name: DIMENSION EXL WITH LM
• Type of Device: DIMENSION EXL WITH LM
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 500 gbc drive; po box 6101; newark DE 19714
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; registration #: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: karl aebig ; 511 benedict ave; tarrytown, NY 10591 ; 9145243102
• MDR Report Key: 6518259
• MDR Text Key: 73614982
• Report Number: 2517506-2017-00417
• Device Sequence Number: 0
• Product Code: LCP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051087
• 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: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/10/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1