MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CHEMISTRY XPT

Model Number 630414595467

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Overdose (1988)

Event Date 04/19/2018

Event Type  Injury  

Event Description

On two separate instances on (b)(6) 2018, the lab tech running ise (ion-selective electrode) tests (sodium, potassium and chloride) on xpt device noticed sodium results were suspiciously low; all daily qc testing earlier had passed.No flags or errors were raised by the xpt system.Specimens with suspiciously low ise results were re-run on another comparable xpt device and showed significantly higher results when compared to initial runs; corrected test reports were issued to providers for 25 orders/pts.Furthermore, on (b)(6) 2018 shortly after instrument was briefly put back in service due to vendor assurance that system was functioning properly, erratic qc results of multiple analytes (not just ise) were seen and the instrument was quickly put back out of service for pt testing.It is unclear if the erratic qc performance is related to low ise results but is being reported since it was seen on the same device and close in time to recent events.Xpt device of interest remains offline since (b)(6) 2018 due to lack of reliability in ise results.Furthermore, pt care was impacted in 3 of 25 pts who received inappropriate treatment (hypertonic saline or k repletion) based on inaccurate ise results initially issued by xpt device.Root cause(s) for low level ise results on given xpt device remain unk at this time, and there is no assurance that cause(s) will not reoccur and produce inaccurate results, especially when there is no evident system warning or flag.

• Brand Name: ADVIA CHEMISTRY XPT
• Type of Device: ADVIA CHEMISTRY XPT
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS; deerfield IL 60015
• MDR Report Key: 7475244
• MDR Text Key: 107169802
• Report Number: MW5076916
• Device Sequence Number: 1
• Product Code: JGS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 630414595467
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other