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 2013-12-09 for APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR 4407205 manufactured by Life Technologies Holdings Pte. Ltd..

Event Text Entries

[4128639] A customer reported that the instrument applied biosystem 7500 fast dx (cat. No. 4407205), with serial number (b)(4) had inconsistent % cv compared to the % cv obtained from two other 7500 fast dx instruments. No patient involvement reported.
Patient Sequence No: 1, Text Type: D, B5


[11512868] Device intended use: the applied biosystems 7500 fast dx real-time pcr instrument with the (b)(4) software version 1. 4 is a 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. The instrument was repaired by replacing the lamp. This is the initial and final report for this event.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3003673482-2013-00031
MDR Report Key3624260
Report Source04,07
Date Received2013-12-09
Date of Report2012-09-07
Date of Event2012-09-01
Date Mfgr Received2012-09-07
Device Manufacturer Date2012-04-01
Date Added to Maude2014-04-01
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 FDA0
Event Location0
Manufacturer ContactKELLI TANZELLA
Manufacturer Street3175 STALEY RD. GRAND ISLAND
Manufacturer CityNEW YORK NY 14072
Manufacturer CountryUS
Manufacturer Postal14072
Manufacturer Phone7167743122
Manufacturer G1LIFE TECHNOLOGIES HOLDINGS PTE. LTD.
Manufacturer StreetBLK 33, MARSILING INDUSTRIAL STATE ROAD 3, # 07-06
Manufacturer CitySINGAPORE 739256
Manufacturer CountrySN
Manufacturer Postal Code739256
Single Use3
Remedial ActionRP
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAPPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR
Generic NameNSU 862.2570
Product CodeNSU
Date Received2013-12-09
Catalog Number4407205
Lot Number275030451
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 2013-12-09

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