MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGANOSTICS INC. DIMENSION XPAND PLUS WITH HM; CLINICAL CHEMISTRY ANALYZER

Model Number DIMENSION XPAND PLUS WITH HM

Device Problem Mechanical Problem (1384)

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

Event Date 09/14/2017

Event Type  malfunction  

Manufacturer Narrative

The customer's quality control (qc) was within range on the day the event occurred.A siemens customer service engineer (cse) was dispatched to the customer site.The cse replaced the integrated multi-sensor technology (imt) rotary valve assembly, peristaltic pump assembly, and imt tubings.The cse ran a system check, which passed.The cse ran qc for electrolytes, and level 3 chloride (cl) was out low.The cse replaced all fluids and sensor.The cse verified the sample probe alignments and conditioned the system.The cse ran dilution check.The cse reran qc, resulting within specification.The customer requested that a preventative maintenance (pm) be performed.The cause of the discordant, low na results is unknown.The instrument is performing according to specifications.No further evaluation of the device is required.

Event Description

The customer obtained discordant low sodium (na) results on a dimension xpand plus with hm instrument.The samples were repeated and still resulted low and were reported to the physician(s), who questioned them.The samples were repeated again on the same instrument, resulting normal as expected.The corrected result was reported to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant low na results.

• Brand Name: DIMENSION XPAND PLUS WITH HM
• Type of Device: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGANOSTICS 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: margarita karan ; 511 benedict ave; tarrytown, NY 10591 ; 9145243105
• MDR Report Key: 6938429
• MDR Text Key: 90155008
• Report Number: 2517506-2017-00762
• Device Sequence Number: 0
• Product Code: JGS
• 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: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DIMENSION XPAND PLUS WITH HM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/23/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1