MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2012-04-11 for LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT 05352894190 manufactured by Roche Molecular Systems.
[2590609]
A customer in (b)(6) filed a complaint alleging that a (b)(6) result was generated when using the lightcycler (b)(9) advanced test for use with the lightcycler 2. 0 ce-ivd ((b)(4)). The customer sent the sample to an associated reference lab and the sample generated the following results: (b)(6). The isolate is being returned for investigative testing / sequencing analysis. It was stated in the case that there was no change made to patient treatment and no patient harm due to the generation of the (b)(6) result in question
Patient Sequence No: 1, Text Type: D, B5
[9852002]
Upon investigation there was no internal nonconformances generated for kit batch p09467. Qc release data for the kit batch met specifications. No product or batch non-conformance was identified. No trend was observed on the complaint issue. No testing of the retention kit was performed as the sequencing of the returned patient sample indicated: the customer-returned isolate was determined to be (b)(6). The re sequence that was obtained lacks an (b)(6) advanced test upstream primer binding site, and therefore cannot be detected. As indicated in the lightcycler mrsa advanced test for use with the lightcycler 2. 0 instrument package insert in the procedural limitations section: interpretation of results: a (b)(6) lightcycler mrsa advanced test does not preclude (b)(6) nasal colonization. Quality control: to date, seven (b)(6) have been distinguished, and several variants of these (b)(6) types have been described. The lightcycler mrsa advanced test is based on a proprietary detection system which is able to detect (b)(6) strains with different molecular sequences in the vicinity surrounding the (b)(6) cassette with the orfx gene. The re types that have been shown to be detected by the lightcycler mrsa test include (b)(6). In addition, sequence analysis of type (b)(6) has shown 100% homology to the primers and probes used in the lightcycler 2. 0 mrsa advanced test. Procedural limitations: though rare, mutations or polymorphisms within the region of the bacterial genome covered by the test's primers and/or probe may impair detection. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[9950222]
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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2012-00017 |
| MDR Report Key | 2526636 |
| Report Source | 01 |
| Date Received | 2012-04-11 |
| Date of Report | 2012-05-11 |
| Date of Event | 2012-01-27 |
| Date Mfgr Received | 2012-05-11 |
| Date Added to Maude | 2012-09-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | VINCENT STAGNITTO |
| Manufacturer Street | 1080 US HWY 202S |
| Manufacturer City | BRANCHBURG NJ 088763733 |
| Manufacturer Country | US |
| Manufacturer Postal | 088763733 |
| Manufacturer Phone | 9082537569 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT |
| Generic Name | REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM FOR MRSA |
| Product Code | JJF |
| Date Received | 2012-04-11 |
| Catalog Number | 05352894190 |
| Lot Number | P09467 |
| Device Expiration Date | 2012-08-31 |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HW 202S BRANCHBURG NJ 08876373 US 08876 3733 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-04-11 |