MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS RAPIDLAB 1260; RL 1260

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 08/28/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Siemens is investigating the issue.The cause for the discordant potassium results is unknown.

Event Description

Customer reported discordant potassium result on the analyzer.There was no injury reported due to this event.

• Brand Name: RAPIDLAB 1260
• Type of Device: RL 1260
• Manufacturer (Section G): SIEMENS HEALTHCARE DIAGNOSTICS; 511 benedict avenue; tarrytown 10591
• Manufacturer Contact: steven andberg ; 2 edgewater drive; norwood, MA 02062 ; 7812693655
• MDR Report Key: 5101851
• MDR Text Key: 26944722
• Report Number: 1217157-2015-00138
• Device Sequence Number: 1
• Product Code: CHL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2015
• Type of Device Usage: N
• Patient Sequence Number: 1