LACTATE REAGENT (LACT 2 X 50)
Received May 11, 2016 · Event occurred Apr 21, 2016
Report 2050010-2016-00002 · MDR key 5648413
Device
Generic name
Nad Reduction/nadh Oxidation, Lactate Dehydrogenase
Manufacturer
Beckman CoulterModel number
LACTATECatalog number
A95550
Product problems
- False Negative Result
- False Negative Result
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
BECKMAN COULTER STUDIES DETERMINED THAT METAMIZOLE (DIPYRONE) INTERFERES WITH BECKMAN COULTER SYNCHRON LACTATE ASSAY: INTERFERENCE SEEN WITH 0.8 MG/ML DIPYRONE (MAX DAILY DOSE) WAS A NEGATIVE BIAS OF 19.9%. INTERFERENCE SEEN WITH 4 MG/ML DIPYRONE (5X DAILY DOSE) WAS A NEGATIVE BIAS OF 41.6%. (B)(4).
Description of Event or Problem
METAMIZOLE (DIPYRONE) HAS BEEN IDENTIFIED AS AN UNDOCUMENTED INTERFERENT WHICH MAY CAUSE FALSE LOW LACTATE (LACT) RESULTS. NO EXTERNAL CUSTOMER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PARTICULAR ISSUE. NO RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THERE WAS NO REPORT OF CHANGE IN PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.