MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-01-27 for NUCLISENS? EASYMAG? DISPOSABLE 280135 manufactured by Biom?rieux Sa.
[65961466]
A customer from the (b)(6) contacted biom? Rieux to report intermittent lls errors in association with the nuclisens? Easymag? Disposable vessels used on one of their easymag? Systems. The customer also ran a test with water using the disposable lot and received lls errors. The customer changed to a different lot and the issue was resolved. The customer was able to recover elute from the samples tested but they were not accepted due to the error messages, so they re-extracted the samples. The customer reported that results were delayed with no impact to patient care. The test reports and disposable vessels were requested from the customer. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[69974679]
An internal biom? Rieux investigation was performed. During the investigation, the issue was reproduced with samples but with a lower frequency. The analysis of data provided by customers showed that these errors were randomly distributed within the run sequences and the sample positions. Investigation with the disposable supplier revealed no issue in raw materials use. The issue involves risk of delayed results for the patients, but not false results. As mentioned in the easymag user manual, the use of an internal control is recommended in order to detect potential nucleic acid extraction issue. All errors that occur during the runs can be found in the results report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2017-00011 |
| MDR Report Key | 6282728 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-01-27 |
| Date of Report | 2017-03-10 |
| Date Mfgr Received | 2017-02-15 |
| Date Added to Maude | 2017-01-27 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | 5, RUE DES BERGES |
| Manufacturer City | GRENOBLE CEDEX 01, FR 38024 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 38024 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLISENS? EASYMAG? DISPOSABLE |
| Generic Name | NUCLISENS? EASYMAG? DISPOSABLE |
| Product Code | JJH |
| Date Received | 2017-01-27 |
| Catalog Number | 280135 |
| Lot Number | Z107NB |
| Device Expiration Date | 2017-11-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX SA |
| Manufacturer Address | 5, RUE DES BERGES GRENOBLE CEDEX 01, FR 38024 FR 38024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-27 |