FDA.reportPublic FDA data

MAUDE MDR 6342974

MDR report key
6342974
Report number
1823260-2017-00379
Event key
0
Event type
3
Date of event
2017-02-01
Date received
2017-02-20
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
1ELECSYS INSULINIMMUNOREACTIVE INSULIN TEST SYSTEMROCHE DIAGNOSTICSCFPNA1201754712215780501R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-02-200

Event Narratives#

N

Patient 1

(B)(4). THE CUSTOMER HAS DISCARDED THE REAGENT PACK IN QUESTION.

D

Patient 1

THE CUSTOMER COMPLAINED OF ISSUES WITH ELECSYS INSULIN QUALITY CONTROLS (QC) SINCE (B)(6) 2017 ON A COBAS 8000 E 602 MODULE. THE CUSTOMER STATED QC STARTED TO DRIFT LOW ON (B)(6) 2017 WHILE USING REAGENT LOT 157805-01. QC WAS RUN ON (B)(6) 2017 AND THE RESULTS WERE OUT OF RANGE. QC WAS RERUN AND THE RESULTS WERE ACCEPTABLE. LATER THAT DAY WHEN QC WAS RUN, THE RESULTS HAD DRIFTED OUT AGAIN. AT THIS POINT, THE CUSTOMER PULLED ALL OF THE PATIENTS THAT HAD BEEN PREVIOUSLY TESTED FOR INSULIN AND REPEATED THE SAMPLES. OUT OF 12 PATIENT SAMPLES, CORRECTED REPORTS WERE ISSUED FOR 5 OF THEM. BASED ON THE DATA PROVIDED FOR THESE 5 PATIENT SAMPLES, THE RESULTS FOR 2 PATIENT SAMPLES WERE ERRONEOUS AND HAD BEEN REPORTED OUTSIDE OF THE LABORATORY. PATIENT 1 INITIAL INSULIN RESULT WAS 12.86 UU/ML. THE REPEAT RESULT WAS 24.1 UU/ML. PATIENT 2 ((B)(6) MALE) INITIAL INSULIN RESULT WAS 14 UU/ML. THE REPEAT RESULT WAS 30 UU/ML. THE CUSTOMER PUT A NEW REAGENT PACK ON THE INSTRUMENT OF 157805-02. QC HAS BEEN FINE SINCE USING THE NEW REAGENT PACK. THE CUSTOMER INDICATED THIS REAGENT PACK WAS FROM THE SAME SHIPMENT AS THE PREVIOUS REAGENT PACK. THE CUSTOMER THINKS THE ISSUE WAS LIMITED TO THE ONE REAGENT PACK. THE CUSTOMER DISCARDED THE REAGENT PACK IN QUESTION. NO ADVERSE EVENT OCCURRED. THE E602 MODULE SERIAL NUMBER WAS (B)(4). THE FIELD SERVICE ENGINEER (FSE) VISITED THE CUSTOMER SITE. THE INSTRUMENT WAS CHECKED AND NO PROBLEMS WERE FOUND. THE INSULIN RESULTS HAVE BEEN STEADY SINCE THE CUSTOMER REPLACED THE REAGENT PACK IN QUESTION. THE CALIBRATION AND QC DATA PROVIDED BY THE CUSTOMER ARE WITHIN SPECIFICATIONS. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED. A GENERAL REAGENT ISSUE WAS NOT OBSERVED SINCE THE QC DATA PROVIDED WAS WITHIN EXPECTATIONS. POTENTIAL ROOT CAUSES OF THE DRIFTING QC RESULTS AND THE DISCREPANT RESULTS ARE LIKELY RELATED TO TRANSPORTATION, STORAGE, CONTAMINATION OR HANDLING ISSUES OF THE INSULIN REAGENT PACK WITH 157805-01. THE ISSUE WAS SOLVED BY REPLACING THE REAGENT PACK.

N

Patient 1

THE CUSTOMER STATED THERE HAVE NOT BEEN ISSUES WITH ANY OTHER REAGENT PACKS. THE ISSUE ONLY OCCURRED WITH THE PARTICULAR REAGENT PACK MENTIONED IN THIS COMPLAINT.