MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2011-09-30 for LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT 05352894190 manufactured by Roche Molecular Systems.
[2239172]
A customer in the (b)(6) who participates in the quality assessment survey (b)(6) reports that incorrect results were generated for 3 out of 4 panel member samples when using the lightcycler (b)(6) advanced test for use with the lightcycler 2. 0 ce-ivd ((b)(4); batch n18705). The panel distributions were (b)(4) ((b)(4)-2011) and (b)(4) ((b)(4) - 2011). The site generated negative results for panel members that were expected to be positive for (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[9474747]
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
[9752897]
The customer alleged that (b)(6) results were generated for 3 out of 4 neqas quality control panel samples that were expected to be (b)(6). Although requested, the panel samples were not provided for further investigation. The customer suspected that their distilled water used to reconstitute the samples as being the cause. Another (b)(6) customer participated in the same neqas survey and generated correct results for all samples. The customer used new mol grade water and reported that all results for a newly distributed neqas panel were as expected. They did not have enough panel material to test the previous panel in which the (b)(6) results were obtained. The investigation included functional testing of retains of the complaint (b)(6) advanced kit lot and all results were within specification. No product non-conformance was identified. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2243471-2011-00087 |
| MDR Report Key | 2270085 |
| Report Source | 01 |
| Date Received | 2011-09-30 |
| Date of Report | 2011-03-09 |
| Date of Event | 2011-05-24 |
| Date Mfgr Received | 2011-08-31 |
| Date Added to Maude | 2012-06-28 |
| 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 | OOI |
| Date Received | 2011-09-30 |
| Catalog Number | 05352894190 |
| Lot Number | N18705 |
| Device Expiration Date | 2012-02-29 |
| Operator | MEDICAL TECHNOLOGIST |
| 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 | 2011-09-30 |