FDA.reportPublic FDA data

MAUDE MDR 6995022

MDR report key
6995022
Report number
1628664-2017-00408
Event key
0
Event type
3
Date of event
2017-01-11
Date received
2017-11-01
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
1PRISM 6 CHANNEL ANALYZERAUTOMATED IMMUNOASSAY ANALYZERABBOTT MANUFACTURING INCMZA06A36-04Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-11-010

Event Narratives#

N

Patient 1

THIS INFORMATION WAS PREVIOUSLY REPORTED IN 1415939-2017-00008, HOWEVER A CORRECTION IN THE MANUFACTURER REPORT NUMBER WAS NEEDED, THE MISTAKE WAS IDENTIFIED ON 1 NOVEMBER 2017. FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, REVIEW OF INSTRUMENT LOGS, A REVIEW OF LABELING AND INSTRUMENT SERVICE. NO ADVERSE TREND WAS IDENTIFIED FOR THE CUSTOMER'S ISSUE. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. THE ISSUE WAS RESOLVED THROUGH STANDARD TROUBLESHOOTING PROCEDURES. THE FIELD SERVICE ENGINEER (FSE) REPORTED THAT THE ABBOTT PRISM XY AXIS CONTROLLER ASSEMBLY, CATALOG NUMBER 1-51110-03, FAILED AT FIRST USE, EMITTING SMOKE FROM THE AREA OF THE X AXIS MOTOR BOARD WITHIN THE ASSEMBLY. THE PRISM INSTRUMENT (S/N (B)(4)) WAS POWERED OFF AND THE SMOKE DISSIPATED. THE X AXIS MOTOR BOARD WAS THEN REPLACED WITH A NEW X AXIS MOTOR BOARD. THE NEW X AXIS MOTOR BOARD ABBOTT PRISM XY GANTRY MOTOR CONTROLLER, CATALOG NUMBER 1-900445-01, ALSO FAILED AT FIRST USE EMITTING SMOKE. THE PRISM INSTRUMENT WAS POWERED OFF AGAIN AND THE SMOKE DISSIPATED. THE ISSUE WAS RESOLVED AT THE CUSTOMER SITE BY REPLACING THE ABBOTT PRISM XY AXIS CONTROLLER ASSEMBLY (1-51110-03). BASED ON ALL AVAILABLE INFORMATION AND ABBOTT DIAGNOSTICS' COMPLAINT INVESTIGATION NO PRODUCT DEFICIENCY WAS IDENTIFIED.

D

Patient 1

AN ABBOTT FIELD SERVICE ENGINEER STATED THAT UPON INSTALLING A NEW XY AXIS CONTROLLER ASSEMBLY ON PRISM ANALYZER SERIAL (B)(4), A SMALL STREAM OF VISIBLE SMOKE WAS OBSERVED COMING FROM THE X AXIS MOTOR BOARD WITHIN THE XY CONTROLLER ASSEMBLY. THE PRISM WAS POWERED OFF. THE SMOKE WAS ISOLATED TO THE X AXIS MOTOR BOARD CARD CAGE AND DISSIPATED AFTER THE PRISM WAS POWERED OFF. THE ENGINEER REPLACED THE X AXIS MOTOR BOARD (PART 1-900445-01). BUT ONCE AGAIN A SMALL STREAM OF SMOKE WAS OBSERVED AND THE PRISM WAS POWERED OFF. NO FIRE WAS OBSERVED. NO INJURIES OCCURRED. THE ENGINEER REPLACED THE XY CONTROLLER ASSEMBLY TO RESOLVE THE ISSUE.