MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-11 for NUCLISENS? LYSIS BUFFER 280134 manufactured by Biom?rieux Sa.
[79950927]
Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[79950928]
Customer notified biom? Rieux of discrepant downstream results following testing of the nuclisens? System. Upon using a new lot of lysis buffer, the customer no longer observed colored eluates. Customer stated there was a delay in reporting results up to several days. There were no incorrect results reported to a clinician; therefore, no impact to patient health. Biom? Rieux investigation will be conducted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00160 |
| MDR Report Key | 6701914 |
| Date Received | 2017-07-11 |
| Date of Report | 2017-09-19 |
| Date Mfgr Received | 2017-08-25 |
| Device Manufacturer Date | 2016-11-28 |
| Date Added to Maude | 2017-07-11 |
| 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 | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOM[?]RIEUX SA |
| 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 | 0 |
| Brand Name | NUCLISENS? LYSIS BUFFER |
| Generic Name | NUCLISENS? LYSIS BUFFER |
| Product Code | PPM |
| Date Received | 2017-07-11 |
| Catalog Number | 280134 |
| Lot Number | Z018LB1LB |
| Device Expiration Date | 2018-10-28 |
| 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 | 2017-07-11 |