FDA.reportPublic FDA data

MAUDE MDR 1161496

MDR report key
1161496
Report number
3005248192-2008-00002
Event key
0
Event type
3
Date of event
2008-08-25
Date received
2008-09-15
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
PAULA MARTIN, SENIOR MGR
Address
1300 EAST TOUHY AVENUE 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
1M2000SPAUTOMATED SAMPLE PREPARATION SYSTEMABBOTT MOLECULAR, INC.KEY9K014-01Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12008-09-1501. O

Event Narratives#

D

Patient 1

THE FRONT HOOD PANEL OF THE M2000SP INSTRUMENT HAS ADHESIVE ON THE DOUBLE-COATED TAPE THAT WAS NOT STRONG ENOUGH TO HOLD THE WINDOW IN PLACE. FIVE INTERNAL INSTANCES HAVE BEEN DOCUMENTED. ADDITIONALLY, FIVE CUSTOMER OBSERVATIONS OF THE HOOD FRONT WINDOW FALLING OFF HAVE BEEN DOCUMENTED. NONE OF THESE INDIVIDUAL INSTANCES HAVE RESULTED IN A MEDICAL DEVICE REPORT (FORM 3500A). HOWEVER, ABBOTT MOLECULAR (AM) TOOK A FIELD ACTION IN 2008. THUS ABBOTT MOLECULAR IS FILING THIS MDR DUE TO THIS SITUATION'S MALFUNCTION AND ABBOTT MOLECULAR'S FIELD CORRECTION.

N

Patient 1

ABBOTT MOLECULAR HAS IDENTIFIED A REPLACEMENT TAPE TO SECURE THE FRONT HOOD PANEL. A CUSTOMER LETTER HAS BEEN ISSUED INFORMING THE CUSTOMERS THAT HAVE A HOOD ON THEIR M2000SP SYSTEM THAT A SERVICE CALL WILL BE SCHEDULED. IF THE CUSTOMER SUSPECTS THAT THE FRONT HOOD PANEL IS LOOSE, THEN THE M2000SP INSTRUMENT IS NOT TO BE USED UNTIL THE SERVICE VISIT IS COMPLETE. ADDITIONAL MODEL #: 9K14-02.