MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-10 for NUCLISENS? LYSIS BUFFER 200292 manufactured by Biom?rieux Sa.
[67390711]
A customer from the (b)(6) reported to biom? Rieux a product performance problem in association with nuclisens? Lysis buffer. The test eluates were colored for blood samples. The customer tested the colored eluates and was not able to communicate results because the samples were inhibited. The customer reported there was a delay more than 48 hours in obtaining results. No results were reported to the physician and there was no impact to patients or their treatment. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00026 |
| MDR Report Key | 6323232 |
| Date Received | 2017-02-10 |
| Date of Report | 2017-08-16 |
| Date Mfgr Received | 2017-03-16 |
| Date Added to Maude | 2017-02-10 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NUCLISENS? LYSIS BUFFER |
| Generic Name | NUCLISENS? LYSIS BUFFER, PRODUCT CODE LDT |
| Product Code | OAI |
| Date Received | 2017-02-10 |
| Catalog Number | 200292 |
| Lot Number | 16092902 |
| Device Expiration Date | 2018-08-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX SA |
| Manufacturer Address | 5 RUE DE BERGES GRENOBLE CEDDEX 01 38024 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-10 |