QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT 4470660

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,07 report with the FDA on 2014-06-27 for QUANTSTUDIO DX REAL-TIME PCR INSTRUMENT 4470660 manufactured by Life Technologies Holdings Pte., Ltd..

Event Text Entries

[4631474] A customer reported a lamp error and instrument failed self test that would cause a run to not start or not generate results after assay completion. The medical device involved was quanstudio dx real-time pcr instrument (cat # 4470660, serial# (b)(4)). No pt involvement reported. The company event tracking number is: (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[12217001] Device is an instrument and is not implanted / explanted. The instrument was investigated on site and was repaired by replacing the lamp and motor controller board. After replacement, functional tests were performed to verify the instrument functionality. Device intended use: the quantstudio dx real-time pcr instrument with quantstudio dx software is intended to perform fluorescence-based pcr to provide detection fo fda cleared and approved nucleic acid sequences in human-derived specimens. The quantstudio dx real-time pcr instrument with quantstudio dx software is intended for in vitro diagnostic use by trained lab technologists in combination with neucleic acid reagent kits/tests manufactured and labeled for diagnostic purposes on this instrument.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3003673482-2014-00012
MDR Report Key3978988
Report Source01,04,07
Date Received2014-06-27
Date of Report2014-03-31
Date of Event2014-03-31
Date Mfgr Received2014-03-31
Device Manufacturer Date2013-03-01
Date Added to Maude2014-08-13
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 ContactKELLI TANZELLA
Manufacturer Street3175 STALEY ROAD
Manufacturer CityGRAND ISLAND NY 14072
Manufacturer CountryUS
Manufacturer Postal14072
Manufacturer Phone7167437743
Manufacturer G1LIFE TECHNOLOGIES PTE, LTD.
Manufacturer CountrySN
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameQUANTSTUDIO DX REAL-TIME PCR INSTRUMENT
Generic NameREAL TIME NUCLEIC ACID AMPLIFICATION
Product CodeOOI
Date Received2014-06-27
Catalog Number4470660
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerLIFE TECHNOLOGIES HOLDINGS PTE., LTD.
Manufacturer AddressSINGAPORE SN


Patients

Patient NumberTreatmentOutcomeDate
10 2014-06-27

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