MTS ID TIPMASTER PIPETTOR MTS9640

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 2007-01-26 for MTS ID TIPMASTER PIPETTOR MTS9640 manufactured by Micro Typing Systems, Inc..

Event Text Entries

[590705] The customer reported that the knob that controls the volume settings on the mts id tipmaster pipettor was damaged. A damaged volume knob could lead to incorrect dispense of fluid which may lead to variations in antigen / antibody ratio and possible erroneous test results. The customer indicated that testing was not being performed at the time of the incident. The pipettor was taken out of use, preventing erroneous results from being reported.
Patient Sequence No: 1, Text Type: D, B5


[7939845] The customer was sent a replacement pipettor. The instrument was returned to ocd depot for evaluation. The customer's complaint was confirmed. The root cause of this event is unknown.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1056600-2007-00022
MDR Report Key821303
Report Source05,06
Date Received2007-01-26
Date of Report2007-01-26
Date of Event2006-12-28
Date Mfgr Received2006-12-28
Device Manufacturer Date2005-05-01
Date Added to Maude2007-03-01
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 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 Received2007-01-26
Model NumberNA
Catalog NumberMTS9640
Lot NumberNA
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key808731
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 2007-01-26

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