FDA.reportPublic FDA data

MAUDE MDR 4996678

MDR report key
4996678
Report number
1823260-2015-03955
Event key
0
Event type
3
Date of event
2015-07-24
Date received
2015-08-12
Adverse event
0
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
0COBAS 6000 E601 MODULEIMMUNOCHEMISTRY ANALYZERROCHE DIAGNOSTICSDBFNA04745922001NAR Y
1COBAS 6000 E601 MODULEIMMUNOCHEMISTRY ANALYZERROCHE DIAGNOSTICSJJENA04745922001NAR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12015-08-120

Event Narratives#

N

Patient 1

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

D

Patient 1

THE CUSTOMER RECEIVED QUESTIONABLE FERRITIN RESULTS FOR ONE PATIENT. TWO SERUM SAMPLES A AND B WERE DRAWN FROM THE PATIENT. SAMPLE A INITIAL RESULT WAS 255.6 NG/ML. THIS RESULT WAS UNEXPECTED BY THE CUSTOMER AND THEY TESTED SAMPLE B WITH A RESULT OF 12.08 NG/ML. THE CUSTOMER REPEATED BOTH SAMPLES IN CUPS AND THE RESULTS FOR SAMPLE A WERE 254.9 NG/ML AND 266.3 NG/ML. THE RESULT FOR SAMPLE B WAS 11.81 NG/ML. ON (B)(6) 2015, THE PATIENT WAS REDRAWN AND THE RESULT WAS 9.58 NG/ML. THIS RESULT CONFIRMED THE LOWER RESULTS FROM SAMPLE B AND FIT WITH THE PATIENT'S CLINICAL PICTURE OF GENERALLY FEELING UNWELL. OTHER ASSAYS WERE REPEATED FOR BOTH SAMPLE A AND B AND THE RESULTS WERE VERY SIMILAR BETWEEN THE TWO SAMPLES. INFORMATION CONCERNING IF ANY RESULT WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED, BUT WAS NOT PROVIDED. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE REAGENT LOT NUMBER WAS 181386. THE EXPIRATION DATE WAS REQUESTED, BUT WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE CHECKED THE ANALYZER AND DID NOT FIND ANY ISSUES. ALL TESTS WERE CALIBRATED AND CONTROLS PERFORMED WITHOUT PROBLEMS. A SPECIFIC ROOT CAUSE COULD NOT BE DETERMINED. ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION WAS REQUESTED, BUT WAS NOT PROVIDED. CONTAMINATION OF SAMPLE A WAS POSSIBLE. BASED ON THE PROVIDED CALIBRATION AND QC DATA, A GENERAL REAGENT ISSUE WAS EXCLUDED.