ABBOTT M2000RT 09K15-01

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-11-29 for ABBOTT M2000RT 09K15-01 manufactured by Abbott Molecular, Inc..

Event Text Entries

[2864933] The abbott m2000 system is intended for use in performing nucleic acid testing in clinical labs. 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 quantitive and qualitative detection of nucleic acid sequences. A customer in (b)(6) reported that there was a paper jam error on the m2000rt during printing. When the customer tried to clear the jam, he observed that the last papers looked and smelled burnt. The customer indicated the papers looked discolored and there was no visible fire or smoke. There was no injury caused by this issue.
Patient Sequence No: 1, Text Type: D, B5


[10223051] Abbott molecular has requested the return of the printer for eval.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3005248192-2011-00023
MDR Report Key2698806
Report Source07
Date Received2011-11-29
Date of Report2011-11-02
Date of Event2011-11-02
Date Mfgr Received2011-11-02
Date Added to Maude2012-08-20
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMR DIMITRIS DEMIRTZOGLOU
Manufacturer Street1300 EAST TOUHY AVENUE
Manufacturer CityDES PLAINES IL 60018
Manufacturer CountryUS
Manufacturer Postal60018
Manufacturer Phone2243617975
Manufacturer G1ABBOTT MOLECULAR, INC.
Manufacturer Street1300 EAST TOUHY AVENUE
Manufacturer CityDES PLAINES IL 60018
Manufacturer CountryUS
Manufacturer Postal Code60018
Single Use3
Remedial ActionRL
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameABBOTT M2000RT
Generic NameREAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM
Product CodeOOI
Date Received2011-11-29
Catalog Number09K15-01
Device AvailabilityN
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerABBOTT MOLECULAR, INC.
Manufacturer Address1300 EAST TOUHY AVENUE DES PLAINES IL 60018 US 60018


Patients

Patient NumberTreatmentOutcomeDate
10 2011-11-29

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