MAUDE Adverse Event Report: BECKMAN COULTER LACTATE AU REAGENT; ACID, LACTIC, ENZYMATIC METHOD

Model Number LACTATE

Device Problem False Negative Result (1225)

Patient Problem No Patient Involvement (2645)

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Beckman coulter studies determined that metamizole (dipyrone) interferes with beckman coulter au lactate assay: interference seen with 0.4 mg/ml dipyrone (half daily dose) ranged from a negative bias of 13.4% to 47.6%.Interference seen with 0.8 mg/ml dipyrone ranged from a negative bias of 28.1% to 62.4%.Interference seen with 4 mg/ml dipyrone ranged from a negative bias of 66.8% to 84.9%.

Event Description

A customer in beckman coulter ireland incorporated reported that metamizole (dipyrone) interferes with beckman coulter au lactate assay and which may cause false low lactate results.No results were reported outside the laboratory.There was no report of change in patient treatment in connection with this event.

• Brand Name: LACTATE AU REAGENT
• Type of Device: ACID, LACTIC, ENZYMATIC METHOD
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• Manufacturer (Section G): BECKMAN COULTER IRELAND INC.; lismeehan; o'callaghan's mills, co. clare ; EI
• Manufacturer Contact: david davis ; 250 s. kraemer blvd; m/s e1.se.01; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 5506148
• MDR Text Key: 40792153
• Report Number: 9680746-2016-00003
• Device Sequence Number: 1
• Product Code: KHP
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: CLASS I EXEM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: LACTATE
• Device Catalogue Number: OSR6193
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1