FDA.reportPublic FDA data

MAUDE MDR 5778304

MDR report key
5778304
Report number
1823260-2016-00875
Event key
0
Event type
3
Date of event
2016-06-17
Date received
2016-07-08
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
1FOLATE IIIACID, FOLIC, RADIOIMMUNOASSAYROCHE DIAGNOSTICSCGNNA07559992190ASKUR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-07-080

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6).

D

Patient 1

THE CUSTOMER STATED THAT LAST YEAR, THEY HAD A COMPLAINT CONCERNING HIGHER PATIENT VALUES OBTAINED WITH FOLATE III (FOL3) ON A COBAS 6000 ANALYZER. PATIENT VALUES WERE HIGHER WHEN COMPARED TO VALUES FROM AN ABBOTT ARCHITECT ANALYZER. THE ABBOTT RESULTS WERE BELIEVED TO BE CORRECT. NO FURTHER DETAILS WERE PROVIDED REGARDING THIS PREVIOUS ISSUE. THE FOL3 REAGENT HAS SINCE BEEN RE-STANDARDIZED. THE CUSTOMER THEN CONTINUED TO WORK WITH THE NEW RE-STANDARDIZED REAGENT AND HAD NO ISSUES. THE CUSTOMER HAS NOW CALLED BACK REPORTING THAT THEY NOW CONTINUE TO HAVE ISSUES WITH THE ASSAY. THEY STATE THAT WHEN PATIENT VALUES RECOVER OVER THE MEASURING RANGE AND DILUTION OF SAMPLES IS REQUIRED, THE DILUTED SAMPLE RESULT IS TOO HIGH WHEN COMPARED TO RESULTS FROM THE ABBOTT ANALYZER. THE CUSTOMER PROVIDED AN EXAMPLE FOR ONE PATIENT SAMPLE THAT HAD AN ERRONEOUS FOL3 RESULT WHICH WAS REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED WITH A VALUE OVER THE MEASURING RANGE AND WAS ACCOMPANIED BY A DATA FLAG INDICATING AS SUCH. NO SPECIFIC VALUE WAS PROVIDED FOR THIS RESULT. THE SAMPLE WAS MANUALLY DILUTED AT A 1:2 DILUTION, THEN RESULTED WITH A FINAL VALUE OF 32 NG/ML. THE 32 NG/ML VALUE WAS REPORTED OUTSIDE OF THE LABORATORY. THE HEMATOLOGIST DID NOT BELIEVE THE RESULT, SO THE SAMPLE WAS SENT TO ANOTHER LABORATORY FOR TESTING ON AN ABBOTT ARCHITECT ANALYZER. THE RESULT FROM THE ABBOTT ARCHITECT ANALYZER WAS 16.3 NG/ML. THE CUSTOMER STATED THAT THEY BELIEVE THAT WHEN THEY DILUTE SAMPLES, SOME KIND OF INTERFERENCE WITH THE FOL3 ASSAY IS INVOLVED. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE SERIAL NUMBER OF THE COBAS 6000 ANALYZER IS (B)(4).

N

Patient 1

THE RESULT FROM THE ABBOTT ARCHITECT ANALYZER WAS CONFIRMED TO BE 16.30 UG/L. THE UNITS OF MEASURE HAVE BEEN UPDATED FROM NG/ML TO UG/L.

N

Patient 1

A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. ADDITIONAL INFORMATION REQUIRED FOR THE INVESTIGATION WAS REQUESTED, BUT NOT PROVIDED. A REAGENT ISSUE CAN MOST LIKELY BE EXCLUDED BASED ON THE PROVIDED CONTROL DATA. POSSIBLE ROOT CAUSES MAY BE RELATED TO THE SAMPLE BEING HEMOLYTIC, EVAPORATION EFFECTS ON THE SAMPLE, OR THE SAMPLE WAS FROM A PATIENT WHO WAS NOT FASTING.