MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM; CLINICAL CHEMISTRY ANALYZER

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 02/07/2017

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the ccc specialist and stated that the serum sample was inadvertently run on the sample id that was urine sample for that patient.Quality controls were within acceptable range.The customer stated that this was not an instrument issue.This is an isolated event and no other samples were affected.The cause of the incorrect creatinine and creatinine clearance results being reported to the physician(s) was due to the user error.The instrument is performing within specifications.No further evaluation of device is required.

Event Description

The operator of a dimension exl with lm instrument contacted a siemens customer care center (ccc).The operator stated that they had obtained urine sample from the patient on (b)(6) 2017 and serum sample from the same patient on (b)(6) 2017.The operator stated that the serum sample was inadvertently run on the sample id that was urine.The result obtained on the serum sample crossed the laboratory information system (lis) as urine and therefore, the urine creatinine was mistakenly reported as <13 mg/dl and the clearance was reported as <2 to the physician(s).The customer stated they usually enter the serum creatinine value manually in their lis when calculating creatinine clearance value.The customer repeated the urine sample and obtained a different result.The customer re-calculated creatinine clearance result, which was also different.The correct creatinine and creatinine clearance results were reported to the physician(s).There are no known reports of patient intervention or adverse health consequence due to the incorrect creatinine and creatinine clearance results.

• Brand Name: DIMENSION EXL WITH LM
• 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 #: 1226181; 101 silvermine road; brookfield CT 06804
• Manufacturer Contact: cassandra kocsis ; 511 benedict ave; tarrytown, NY 10591 ; 9145242687
• MDR Report Key: 6417546
• MDR Text Key: 70420363
• Report Number: 2517506-2017-00259
• 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: 03/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• 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: 02/23/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2011
• 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