APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR 4407205

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2014-06-27 for APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR 4407205 manufactured by Life Technologies Holdings Pte. Ltd..

Event Text Entries

[4822217] "a customer reported high background in data of the results reported when using applied biosystems 7500 fast dx (cat no 4407205, serial no (b)(4). " the high background led to incorrect assay results. No pt involvement reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5


[11940842] Device is an instrument and is not implanted/explanted. The instrument was investigated on site. The field service engineer (fse) removed tape from heated cover and run new background, the problem was solved. Device intended use: the applied biosystems 7500 fast dx real-time pcr instrument with the sds software version 1. 4 is an real-time nucleic acid amplification and detection system that measures nucleic acid signals from reverse transcribed rna and converts them to comparative quantitative readouts using fluorescent detection of dual-labeled hydrolysis probes. The 7500 fast dx real-time pcr instrument is to be used only by technologists trained in laboratory techniques, procedures, and on use of the analyzer.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3003673482-2014-00035
MDR Report Key3978836
Report Source04,07
Date Received2014-06-27
Date of Report2013-10-23
Date of Event2013-10-23
Date Mfgr Received2013-10-23
Device Manufacturer Date2009-07-01
Date Added to Maude2014-08-14
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 Phone7167743122
Manufacturer G1LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAPPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR
Generic NameINSTRUMENTATION FOR CLINICAL MULTIP
Product CodeNSU
Date Received2014-06-27
Catalog Number4407205
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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