FDA.reportPublic FDA data

MAUDE MDR 6519924

MDR report key
6519924
Report number
3008344661-2017-00037
Event key
0
Event type
3
Date of event
2016-06-09
Date received
2017-04-25
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
NOEMI ROMERO-KONDOS, RN BSN
Address
100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 ABBOTT PARK IL 60064 US
Phone
224-224-2246
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ARCHITECT AFPALPHA-FETOPROTEINABBOTT IRELANDLOK03P36-2654021LH00Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-250

Event Narratives#

N

Patient 1

THE CUSTOMER OBSERVED A SINGLE FALSE ELEVATED AFP RESULTS USING ARCHITECT AFP, LIST 3P36-25 ((B)(4) LIST NUMBER 3P36-26), LOT 54021LH00. THE TICKET SEARCHES DETERMINED NORMAL COMPLAINT LOT AND NO TREND FOR THE ISSUE FOR THE PRODUCT. HISTORICAL PERFORMANCE OF LOT 54021LH00 WAS EVALUATED USING WORLD WIDE DATA FROM ABBOTT LINK. THE PATIENT DATA WAS ANALYZED AND COMPARED TO AN ESTABLISHED CONTROL LIMIT. THIS EVALUATION INDICATED THAT THE PATIENT MEDIAN RESULT FOR THIS LOT IS WITHIN THE ESTABLISHED CONTROL LIMITS AND NO UNUSUAL REAGENT LOT PERFORMANCE WAS IDENTIFIED. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LOT DID NOT IDENTIFY ANY ISSUES ASSOCIATED WITH THE CUSTOMER OBSERVATION. A REVIEW OF LABELING CONCLUDED THAT THE ISSUE IS SUFFICIENTLY ADDRESSED. A MALFUNCTION WAS IDENTIFIED AS THE DEVICE FAILED TO MEET PERFORMANCE SPECIFICATIONS OR OTHERWISE PERFORM AS INTENDED AT THE CUSTOMER SITE. HOWEVER, A SYSTEMIC ISSUE AND/OR PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

D

Patient 1

THE CUSTOMER STATED THAT THE ARCHITECT ANALYZER GENERATED A FALSELY ELEVATED AFP RESULT ON ONE PATIENT AFTER SURGERY. THE RESULTS PROVIDED WERE: (B)(6) 2016 = 18NG/ML / PREVIOUSLY (UNKNOWN DATE) 5.0NG/ML / (B)(6) 2016 = 5.6NG/ML. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.