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.
[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
| Report Number | 2243471-2011-00081 |
| MDR Report Key | 2237483 |
| Report Source | 05 |
| Date Received | 2011-09-07 |
| Date of Report | 2012-04-13 |
| Date of Event | 2011-08-03 |
| Date Mfgr Received | 2012-04-13 |
| Date Added to Maude | 2012-06-25 |
| 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 | 0 |
| 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 | MRSA REAL TIME NUCLEIC ACID AMPLIFICATION SYSTEM |
| Product Code | OOI |
| Date Received | 2011-09-07 |
| Catalog Number | 05205727190 |
| Lot Number | P05725 |
| Device Availability | N |
| 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 | 2011-09-07 |