MTS ID TIPMASTER PIPETTOR MTS9640 6900954

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-11-10 for MTS ID TIPMASTER PIPETTOR MTS9640 6900954 manufactured by Micro Typing Systems, Inc..

Event Text Entries

[16498558] Investigation into this event confirmed that the pipettor was not performing as expected. The device was returned to ocd and a replacement sent to the customer.
Patient Sequence No: 1, Text Type: N, H10


[16706996] A customer observed that the pipettor was not aspirating properly. Dispensing variable volumes of reagents / samples could cause erroneous test results. There was no report of patient harm as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1056600-2006-00276
MDR Report Key781355
Report Source05,06
Date Received2006-11-10
Date of Report2006-11-10
Date of Event2006-10-07
Date Mfgr Received2006-10-07
Date Added to Maude2006-11-16
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL TECHNOLOGIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactDAVID HAGEN, SITE MANAGER
Manufacturer Street1295 SW 29TH AVENUE
Manufacturer CityPOMPANO BEACH FL 33069
Manufacturer CountryUS
Manufacturer Postal33069
Manufacturer Phone9546239528
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMTS ID TIPMASTER PIPETTOR
Generic NameMANUAL PIPETTOR
Product CodeGJG
Date Received2006-11-10
Model NumberMTS9640
Catalog Number6900954
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key769137
ManufacturerMICRO TYPING SYSTEMS, INC.
Manufacturer Address1295 S.W. 29TH AVE. POMPANO BEACH FL 33069 US
Baseline Brand NameMTS ID TIPMASTER PIPETTOR
Baseline Generic NameMANUAL PIPETTOR
Baseline Model NoMTS9640
Baseline Catalog NoID TIPMASTER PIPETTOR
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
10 2006-11-10

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