COBAS AMPLIPREP/ COBAS TAQMAN 48 WITH AMPLILINK SOFTWARE V 3.2.3

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2010-08-05 for COBAS AMPLIPREP/ COBAS TAQMAN 48 WITH AMPLILINK SOFTWARE V 3.2.3 manufactured by Roche Diagnostics Ltd..

Event Text Entries

[1632294] A customer in the (b)(6) reported that they received an erroneous result on one patient sample with the cobas ampliprep / cobas taqman hiv-1 test us-ivd (m/n 03542998190 batch n02337). The customer stated that the sample produced an initial result of greater than 10 million copies/ml. When they diluted the sample 1:100, they received a result of less than 48 copies/ml both were run on the same specimen collection. The result was not reported.
Patient Sequence No: 1, Text Type: D, B5


[8678531] The issue is under investigation. No conclusions can be drawn at this time.
Patient Sequence No: 1, Text Type: N, H10


[9134947] Follow up report 1. Device evaluated by manufacturer. Performance tests performed. Optical problem. Failure could not be reproduced during in house investigation. Conclusion: device evaluated and alleged failure could not be duplicated - cause of event unknown. The investigation of the issue has shown that cobas taqman 48 analyzer photometer intensity increases can occur, in rare instances, affecting the dark and bright signals of the photometer. This can possibly lead to the generation of over-quantitated or invalid results. The issue is rare, occurs sporadically, and is not reproducible. The root cause of the intensity increase has not been determined. (b)(4). All potentially affected assays have been assessed and it has been determined that the issue is not likely to cause any adverse health consequences.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2243471-2010-00034
MDR Report Key1784886
Report Source*
Date Received2010-08-05
Date of Report2010-07-27
Date of Event2010-07-22
Date Mfgr Received2010-07-27
Date Added to Maude2011-05-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Manufacturer ContactVINCENT STAGNITTO
Manufacturer Street1080 US HWY 202
Manufacturer CityBRANCHBURG NJ 088763733
Manufacturer CountryUS
Manufacturer Postal088763733
Manufacturer Phone9082537569
Manufacturer G1ROCHE DIAGNOSTICS LTD.
Manufacturer StreetFORRENSTRASSE
Manufacturer CityROTKREUZ, ZUG 6343
Manufacturer CountrySZ
Manufacturer Postal Code6343
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOBAS AMPLIPREP/ COBAS TAQMAN 48 WITH AMPLILINK SOFTWARE V 3.2.3
Generic NameANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE
Product CodeJJF
Date Received2010-08-05
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerROCHE DIAGNOSTICS LTD.
Manufacturer AddressFORRENSTRASSE ROTKREUZ, CH-5343 SZ CH-5343 S


Patients

Patient NumberTreatmentOutcomeDate
10 2010-08-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.