MAUDE Adverse Event Report: NORMAND-INFO S.A.S REMISOL ADVANCE DATA MGR; CALCULATOR/DATA PROCESSING MODULE

Catalog Number A58052

Device Problem High Test Results (2457)

Patient Problem No Code Available (3191)

Event Date 04/16/2014

Event Type  Injury  

Event Description

The customer reported obtaining an erroneously high potassium (k) result of 5.7mmol/l from a hemolyzed sample which was released out of the laboratory due to incorrectly configured rule at the remisol advance data mgr.Based upon the falsely elevated k result, the customer stated that one (1) emergency room pt was admitted to the hospital and administered insulin and sodium polystyrene sulfonate to lower the pt's k level.Following treatment, the pt was redrawn and a k result of 3.3 mmol/l was obtained.The pt was then given potassium intravenously (iv) to elevate the pt's potassium level back to the normal range.

Manufacturer Narrative

The customer configured a rule at remisol advance data mgr to add a hemolysis index test to any test order containing k.However, the rule was not configured correctly and remisol advance failed to add the hemolysis index test.The sample in question was hemolyzed and a falsely elevated k result was generated.The hemolysis index test would have alerted the user to the presence of hemolysis.However, since a hemolysis index test was not run to indicate the presence of hemolysis, the falsely elevated k result was released out of the laboratory.In conclusion, failure mode of the event is attributed to use error as the customer incorrectly configured the rule at the remisol advance data mgr.Applications specialist assisted the customer with resolving the issue over the telephone by correcting the rule to add a hemolysis index test.

• Brand Name: REMISOL ADVANCE DATA MGR
• Type of Device: CALCULATOR/DATA PROCESSING MODULE
• Manufacturer (Section D): NORMAND-INFO S.A.S; 57 grand place; arras 0000 6202; FR 000062028
• Manufacturer Contact: guy pernet ; 57 grand place; arras 00006-2028 ; FR 000062028 ; 21217574
• MDR Report Key: 3843572
• MDR Text Key: 17932231
• Report Number: 3006543086-2014-00001
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A58052
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/17/2014
• Initial Date FDA Received: 05/17/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention