FDA.reportPublic FDA data

MAUDE MDR 7965057

MDR report key
7965057
Report number
3005248192-2018-00013
Event key
0
Event type
3
Date of event
2018-09-27
Date received
2018-10-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. JOE HUTSON
Address
1300 E. TOUHY AVE. DES PLAINES IL 60018 US
Phone
224-224-2243
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ABBOTT M2000SP INSTRUMENTCLINICAL SAMPLE CONCENTRATORABBOTT MOLECULAR, INC.JJH09K14-02Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-10-150

Event Narratives#

N

Patient 1

AN ELEVATED COMPLAINT INVESTIGATION WILL BE PERFORMED. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN (B)(6) USING THE M2000SP INSTRUMENT, LIST NUMBER 09K14-02 WHICH IS ALSO APPROVED FOR USE IN THE UNITED STATES.

D

Patient 1

THE ABBOTT M2000 SYSTEM IS INTENDED FOR USE IN PERFORMING NUCLEIC ACID TESTING IN CLINICAL LABORATORIES. IT IS COMPRISED OF THE ABBOTT M2000SP AND THE ABBOTT M2000RT INSTRUMENTS. THE ABBOTT M2000SP IS AN AUTOMATED SYSTEM FOR PERFORMING SAMPLE PREPARATION FOR NUCLEIC ACID TESTING. THE ABBOTT M2000RT IS AN AUTOMATED SYSTEM FOR PERFORMING FLUORESCENCE-BASED PCR TO PROVIDE QUANTITATIVE AND QUALITATIVE DETECTION OF NUCLEIC ACID SEQUENCES. THE CUSTOMER REPORTED THAT THE M2000SP INSTRUMENT HAD LEAKAGE FROM THE WASTE TUBE. THE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S LOCATION. THE FSE PERFORMED AN INSPECTION OF THE WASTE TUBING. THE WASTE TUBE HAD A CRACK WHERE LIQUID WASTE POURED OUT IN THE BACK OF THE M2000SP INSTRUMENT CABINET, AND THE FSE REPORTED THERE WAS FLUID ON THE FLOOR. THE CUSTOMER WORE GLOVES AND A LAB COAT WHILE CLEANING UP THE FLUID. THE FSE REPLACED THE WASTE TUBE AND COMPLETED A FLUSH OF THE WASTE TUBE WHILE LOOKING AND MOVING THE WASTE TUBING SYSTEM. ALL CHECKS AND CALIBRATIONS PASSED, THE INSTRUMENT WAS WORKING PER SPECIFICATION, AND NO FURTHER ACTION WAS REQUIRED. THE CUSTOMER ACCEPTED THE INSTRUMENT FOR ROUTINE USE. THIS MEDICAL DEVICE REPORT (MDR) IS SUBMITTED ON THE BASIS THAT IF THIS OBSERVATION WAS CAUSED BY AN ABBOT PRODUCT MALFUNCTION AND THAT MALFUNCTION WERE TO RECUR, LIQUID LEAKAGE ONTO THE WALKING SURFACE HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH. NO PATIENT WAS INVOLVED. THE OBSERVATION WAS MADE BY THE M2000SP INSTRUMENT USER. THIS INCIDENT IS BEING REPORTED TO FDA BECAUSE THE INCIDENT OCCURRED IN (B)(6) USING THE M2000SP INSTRUMENT, LIST NUMBER 09K14-02 WHICH IS ALSO APPROVED FOR USE IN THE UNITED STATES.