LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT 05205727190

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-09-07 for LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT 05205727190 manufactured by Roche Molecular Systems.

Event Text Entries

[2170962] A customer site in the united states alleged that a (b)(6) result was generated for one sample when using the (b)(6) test for use with the lightcycler 2. 0 instrument us-ivd ((b)(4)). The sample was culture (b)(6) for (b)(6). It is unknown as to what strain of (b)(6) the sample is. The sample will be sent for sequencing analysis. The (b)(6) result was not reported to physicians.
Patient Sequence No: 1, Text Type: D, B5


[9455873] A definitive conclusion cannot be drawn at this time, as the investigation into this issue is ongoing. The outcome of the investigation will be communicated through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[9801832] (b)(4). The customer reported that a sample generated a (b)(6) result using the lightcycler mrsa advanced test while the culture result was (b)(6). The sample was submitted for sequence analysis. One sequence was obtained from the sample that covers the target region (b)(4). The mrsa advanced test is only designed to detect mrsa types re1, re2, re3, and re7. There is no binding site for the assay upstream primer in re11 sequences. Lack of an upstream primer binding site would result in a (b)(6) test result for the mrsa advanced test. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2243471-2011-00081
MDR Report Key2237483
Report Source05
Date Received2011-09-07
Date of Report2012-04-13
Date of Event2011-08-03
Date Mfgr Received2012-04-13
Date Added to Maude2012-06-25
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 ContactVINCENT STAGNITTO
Manufacturer Street1080 US HWY 202S
Manufacturer CityBRANCHBURG NJ 088763733
Manufacturer CountryUS
Manufacturer Postal088763733
Manufacturer Phone9082537569
Single Use0
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT
Generic NameMRSA REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM
Product CodeOOI
Date Received2011-09-07
Catalog Number05205727190
Lot NumberP05725
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerROCHE MOLECULAR SYSTEMS
Manufacturer Address1080 US HW 202S BRANCHBURG NJ 08876373 US 08876 3733


Patients

Patient NumberTreatmentOutcomeDate
10 2011-09-07

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