MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION® EXL WITH LM; 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 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the siemens technical applications specialist (tas) to report the discordant creatinine result.Quality control (qc) was within range.The tas was dispatched to the customer site.The tas found that the probe alignment to the small sample cup (ssc) was too high.The tas aligned the small sample cup (ssc) probe.The tas recalibrated the depth into ssc, which was acceptable.The cause of the discordant creatinine result is unknown.The instrument is performing according to the specifications.No further evaluation of this device is required.

Event Description

A discordant, falsely low creatinine result was obtained upon repeat testing on one patient sample on a dimension exl with lm instrument.The discordant result was not reported to the physician(s).The sample was repeated on the same instrument, resulting higher.The correct result was reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant creatinine 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 6101
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 101 silvermine road; registration #:1226181; brookfield CT 06804
• Manufacturer Contact: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 7003736
• MDR Text Key: 92115213
• Report Number: 2517506-2017-00803
• Device Sequence Number: 0
• Product Code: CGX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130276
• 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: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2017
• 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
• Date Manufacturer Received: 10/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/12/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1