FDA.reportPublic FDA data

MAUDE MDR 3037731

MDR report key
3037731
Report number
1415939-2013-00168
Event key
0
Event type
3
Date received
2013-04-05
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
NOEMI ROMERO-KONDOS, RN BSN
Address
100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 ABBOTT PARK IL 60064 US
Phone
847-847-8479
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ARCHITECT INSULINABBOTT LABORATORIESCFP08K41-2625020LP46Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-04-050

Event Narratives#

N

Patient 1

ACCURACY TESTING WAS PERFORMED WITH AN IN-HOUSE RETAINED REAGENT KIT OF ARCHITECT INSULIN ASSAY LIST 08K41-26, LOT 25020LP46. FOUR MEMBERS OF AN INSULIN PANEL WERE TESTED IN REPLICATES OF FIVE ON ONE ISYSTEMS ANALYZER. ALL RESULTS MET SPECIFICATIONS, INDICATING THAT ASSAY PERFORMANCE HAS NOT BEEN COMPROMISED. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE ARCHITECT INSULIN ASSAY PACKAGE INSERT CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. THE CUSTOMER ISSUE WAS ISOLATED TO A SINGLE PATIENT SAMPLE. NO FURTHER TROUBLESHOOTING OR INFORMATION FROM THE CUSTOMER SITE WAS PROVIDED. BASED ON THE INFORMATION RECEIVED FROM THE CUSTOMER SITE AND THE RESULTS OF THE CURRENT EVALUATION, IT CAN BE CONCLUDED THAT THE ARCHITECT INSULIN ASSAY IS PERFORMING AS EXPECTED WITH NO PRODUCT ISSUES FOUND. A PRODUCT MALFUNCTION WAS NOT IDENTIFIED.

D

Patient 1

THE CUSTOMER REPORTS FALSELY ELEVATED ARCHITECT INSULIN ASSAY RESULTS FOR ONE PATIENT. AN INITIAL RESULT OF 291.9 UU/ML WAS GENERATED (CURRENT SAMPLE, DATE UNKNOWN). HOWEVER, THIS SAMPLE WAS ALSO TESTED WITH THE AUTO-DILUTION MODE OF THE ANALYZER (1:2 DILUTION) AND A FINAL RESULT OF 562.3 UU/ML WAS GENERATED. THE SAMPLE WAS RETESTED WITH AN UNDILUTED RESULT OF 299.6 UU/ML AND AN AUTO-DILUTION RESULT OF 543.4 UU/ML. THE CUSTOMER BELIEVES THAT THE AUTO-DILUTION RESULT IS CORRECT BECAUSE A PREVIOUS SAMPLE TAKEN (ON OR ABOUT 29 MARCH 2013) FROM THIS PATIENT HAD GENERATED A RESULT OF 590.9 UU/ML. THE CUSTOMER THEN PERFORMED MANUAL DILUTIONS OF THE SAMPLE WITH THE FOLLOWING RESULTS: CURRENT SAMPLE = 567.7 UU/ML (1:2) AND 843.2 UU/ML (1:5); 29 MARCH 2013 SAMPLE = 906.9 UU/ML (1:5) AND 1009.6 UU/ML (1:10). THE PATIENT'S INSULIN ANTIBODY TEST GENERATED A RESULT OF GREATER THAN 50 U/ML. THERE IS NO REPORT OF ANY IMPACT TO PATIENT CARE DUE TO THIS ISSUE.

N

Patient 1

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. (B)(4).