MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04 report with the FDA on 2010-09-16 for LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT 05352894190 manufactured by Roche Molecular Systems.
[16572196]
Additional / corrected information: updated to include customer data. An evaluation of the patient specimens, customer data, product labeling and complaint history were performed. Manufacturer narrative: sequencing analysis was performed for the samples and gave the following results: no sequence information could be obtained for three of the samples (samples 2, 5 and 7). It was attempted to obtain amplicons (amplified nucleic acid material) for sequencing using many different primer combinations but attempts were not successful. It cannot be determined why these samples either generated a (b)(6) result (samples 2 and 5) or generated a tm peak at 55 degrees c (sample 7). It is possible that the failure is due to low concentrations of the target region in the lysates. However, this cannot be conclusively determined. The sequences obtained from samples 3, 11 and 22 each lack an (b)(6) advanced test upstream primer binding site. This is likely the cause of the (b)(6) results for these samples. Samples 16, 18 and 30 have sequences that cover the (b)(6) advanced test target region. The sequences perfectly match the (b)(6) advanced primers. The sequences contain mismatches to the (b)(6) advanced probes. One mismatch is found under the donor probe and two mismatches are under the acceptor probe. These mismatches would likely affect the tm, resulting in a melting peak below cut-off. As specified within the product labeling: though rare, mutations within the region of the bacterial genome covered by the lightcycler (b)(6) advanced test primers and/or probe may result in the failure to detect the bacteria. To date, five sccmec types (i-v) have been distinguished, and several variants of these sccmec types have been described. The lightcycler (b)(6) advanced test is based on a proprietary detection system which is able to detect (b)(6) strains in different molecular sequences in the vicinity surrounding the right extremity (re) junction of the sccmec cassette with the orfx gene. The different re types which are detected by the lightcycler (b)(6) advanced test are referred to as re2, re3, and re7 (proprietary nomenclature). The lightcycler (b)(6) advanced test is a qualitative in vitro diagnostic test for the direct detection of nasal colonization with ((b)(6)) to aid in the prevention and control of (b)(6) infections in healthcare settings. The lightcycler (b)(6) advanced test is not intended to diagnose (b)(6) infections nor to guide or monitor treatment for (b)(6) infections. An analysis of previous complaints was performed: no previous related complaints were filed related to the complaint lot number m13263. Seven complaints filed for the overall issue of (b)(6) results with this assay were identified: in most of these complaints, the customers observed shifted tm, as seen with this case. In one of the previous complaints, as observed in this reported complaint case, there was a sample that did not have a melting peak but was culture (b)(6). For that sample, the sequence lacked an (b)(6) advanced upstream primer binding site, which likely was the cause of the (b)(6) result. This sample sequence was determined to be re4, which is not captured by the lightcycler (b)(6) advanced test. Based on the available information, there was no indication of a product malfunction / non-conformance. Additionally, this reported issue did not lead to serious injury / death. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[16923094]
A customer site in (b)(6) was performing an evaluation of the lightcycler (b)(6) advanced test and observed five false negative results compared to biomerieux chromagar culture results. Additionally, the customer indicated that coagulase testing was performed and all five samples were confirmed to be positive for mrsa. The customer specified that the evaluation was performed with known positive cultures, which were identified as positive in (b)(6) 2010. As the false negative results were generated during an evaluation, there was no patient impact.
Patient Sequence No: 1, Text Type: D, B5
[17057978]
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 | 2243471-2010-00037 |
| MDR Report Key | 1836227 |
| Report Source | 01,04 |
| Date Received | 2010-09-16 |
| Date of Report | 2010-12-01 |
| Date of Event | 2010-08-17 |
| Date Mfgr Received | 2010-12-01 |
| Device Manufacturer Date | 2010-01-08 |
| Date Added to Maude | 2012-01-06 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| 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 | 2010-09-16 |
| Catalog Number | 05352894190 |
| Lot Number | M13263 |
| Device Expiration Date | 2011-01-31 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2010-09-16 |