AFFYMETRIX GENECHIPS *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-01-07 for AFFYMETRIX GENECHIPS * manufactured by Roche Diagnostics Corp.

Event Text Entries

[313732] Reporter could provide some open info. There are six miscall results in that of amplichip cyp 450. The same detections at differnt times for the same sample results in the different genotype for the same person. Roche employee cannot acknowledge this false-positive result because they kept their profits for themselves. In traditional hybridization chips there maybe one particular example that the first target dna chain hybridization with pp (perfect match) and pm (mismatch) probes result in the different tm1 [tmp(pp)>tm1(pp) >tm1(pm)>tmm(pm), tmp(pp)for the real-positive result, tmm (pm) for the real-positive mismatch result] and the second sample dna chain hybridization with the other sequences of the first target dna chain (from clinical blood and tissue samples) result in the tm(s1s2)[tm(s1s2)>tmp(pp)]. Ip is the signal/noise for tmp(pp)/tmm(pm) real-positive result. I1 for the tm1(pp)/tm1(pm) normal false-positive result. Then i1tm1(pm)>tm1(pm). There are some real false-positive results for affymetrix genechips because there is no accurate formula capable of calculating the temperature value of melting point (tm) of dna probes.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1033817
• MDR Report Key: 563957
• Date Received: 2005-01-07
• Date Added to Maude: 2005-01-10
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: AFFYMETRIX GENECHIPS
• Generic Name: *
• Product Code: MAO
• Date Received: 2005-01-07
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 553691
• Manufacturer: ROCHE DIAGNOSTICS CORP
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2005-01-07