LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT 05352894190

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2012-07-11 for LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT 05352894190 manufactured by Roche Molecular Systems.

Event Text Entries

[10144691] (b)(4). No product or batch non-conformance was identified. Upon investigation there was no trend found in the field. Qc release data for p11990 was reviewed and the issue of discrepant results has not been observed. There have not been any manufacturing non-conformance reports for batch p11990. Retain testing of the complaint batch p01607 was tested for this case and generated valid and acceptable results. The customer returned panel was sent for sequencing analysis. Sequencing analysis indicated the following: - the sample was determined to be scc-mec-right-extremity (re) junction type re4. - the re4 sequence that was obtained lacks a lightcycler (b)(6) advanced test upstream primer binding site, and therefore cannot be amplified. - this is the likely cause of the (b)(6) results for this sample by the (b)(6) advanced test. The light cycler (b)(6) advanced test for use with the lightcycler 2. 0 instrument package insert (m/n (b)(4)) indicates in the external positive control (epc) section that "(b)(6) strains representing right extremity (re) junction 3 and re7 types, if available may be used as additional external positive controls to monitor assay primers and probes not directly controlled in the assay. "also, the package insert indicates that "the re types that have been shown to be detected by the lightcycler (b)(6) test include re2, re3, and re7. " (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[21759673] A customer in (b)(6) filed a complaint alleging that a (b)(6) result was generated when using the lightcycler mrsa advanced test for use with the lightcycler 2. 0 ce-ivd (m/n 05352894190; batch p11990). Specifically, the customer stated that they ran a user defined controlled, which was known to contain the (b)(6), however, (b)(6) results were generated with the lightcycler mrsa advanced test for use with the lightcycler 2. 0 ce-ivd (m/n 05352894190; batch p11990).
Patient Sequence No: 1, Text Type: D, B5


[21923242] No conclusion can be drawn at this time as the investigation into this issue is ongoing. The conclusion of the investigation will be submitted through a follow-up report. The associated us product is m/n 05205727190, k091409. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2243471-2012-00031
MDR Report Key2651467
Report Source01,05
Date Received2012-07-11
Date of Report2012-09-26
Date of Event2012-06-13
Date Mfgr Received2012-09-26
Date Added to Maude2012-10-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA0
Report to FDA0
Event Location0
Manufacturer ContactVINCENT STAGNITTO
Manufacturer Street1080 US HWY 202S
Manufacturer CityBRANCHBURG NJ 088763733
Manufacturer CountryUS
Manufacturer Postal088763733
Manufacturer Phone9082537569
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameLIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT
Generic NameREAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM FOR MRSA
Product CodeOOI
Date Received2012-07-11
Catalog Number05352894190
Lot NumberP11990
Device Expiration Date2012-09-29
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 2012-07-11

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