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 2016-12-05 for NUCLISENS? EASYMAG? DISPOSABLE 280135 manufactured by Biomerieux Sa.
[61460134]
A customer in (b)(6) notified biom? Rieux of a product problem when using nuclisens easymag disposable product. The customer reported multiple lls issues on their instrument, approximately 2-4 times per use. The customer indicated occasionally having delays greater than 24 hours depending on the time of day the lls error occurred. In addition, the customer indicated having incidences where the sample was nsq for repeat testing thus requiring re-collection from the patient. The customer reported that a large majority of lls errors for the product lot are occurring in vessel position 7 and 4, and randomly in other positions. When the lls error occurs, re-extraction is required every time per customer procedure. The instrument was recently serviced and found to be in good condition. The disposable vessels, instrument log, application and user logs were requested from the customer. An internal biom? Rieux investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[70917219]
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 | 3002769706-2016-00481 |
| MDR Report Key | 6145757 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-05 |
| Date of Report | 2017-03-10 |
| Date Mfgr Received | 2017-02-15 |
| Date Added to Maude | 2016-12-05 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD 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 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 | 2016-12-05 |
| Catalog Number | 280135 |
| Lot Number | Z107NA |
| Device Expiration Date | 2017-12-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | 5, RUE DES BERGES GRENOBLE, CEDEX 01 38024 FR 38024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-05 |