FDA.reportPublic FDA data

MAUDE MDR 6529225

MDR report key
6529225
Report number
1823260-2017-00917
Event key
0
Event type
3
Date of event
2017-04-06
Date received
2017-04-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
NA MICHAEL LESLIE
Address
9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US
Phone
317-317-3175
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROBNP II, N-TERMINAL PRO B-TYPE NATRIURETIC PEPTIDETEST,NATRIURETIC PEPTIDEROCHE DIAGNOSTICSNBCNA04842464190ASKUR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-280

Event Narratives#

N

Patient 1

(B)(4). THIS EVENT OCCURRED IN (B)(6).

D

Patient 1

THE CUSTOMER RECEIVED QUESTIONABLE ELECSYS PROBNP II IMMUNOASSAY RESULTS FOR ONE PATIENT FROM A 6000 E 601 MODULE. THE SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT SAMPLE REPEATEDLY HAD A RESULT OF

N

Patient 1

A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION AND THE CUSTOMER?S LOW RESULT WAS CONFIRMED. FURTHER TESTING OF THE PATIENT SAMPLE FOUND IT DID NOT CONTAIN THE GENETIC MUTATIONS (R72H AND E69D). THE SAMPLE WAS THEN TESTED WITH THE GEN 1 PROBNP ASSAY WHICH USES A POLYCLONAL ANTIBODY INSTEAD OF THE MONOCLONAL ANTIBODY USED IN THE GEN 2 ASSAY. THE RESULT WAS NEGATIVE FOR PROBNP. THE RESULTS AFTER THE SAMPLE WAS TREATED WITH HETEROPHILIC BLOCKING TUBES (HBT) INDICATED NO INTERFERENCE WITH IGM. FURTHER TESTING SHOWED THAT AN INTERFERENCE WITH RUTHENIUM WAS VERY UNLIKELY. THE SAMPLE WAS THEN TESTED FOR PROBNP ON A SIEMENS IMMULITE AND THE RESULT WAS 172 NG/L AND WAS CLEARLY ABOVE THE CUT OFF VALUE. FURTHER CLARIFICATION OF THE DISCREPANCY WAS NOT POSSIBLE WITH THE AVAILABLE METHODS AND THE CURRENT STATE OF THE ART.