MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-08 for NUCLISENS? LYSIS BUFFER 280134 manufactured by Biomerieux, Sa.
[128788255]
A customer in the united states reported that their internal control (ms2 plasmid) values are lower than expected after changing lots of nuclisens? Lysis buffer (lot z019ko1) for nucleic acid extraction. The customer was testing patient rectal samples with a downstream application, luminex gpp (gastrointestinal pathogen panel). The customer stated there was no patient impact, as they repeat testing when there is an internal control failure. If it fails twice the test is reported as invalid. The customer reported that they had to do this a few times, and there have been results that were delayed more than 24 hours. In these cases, the customer did not know if patient results or treatment was impacted. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00234 |
| MDR Report Key | 8053433 |
| Date Received | 2018-11-08 |
| Date of Report | 2019-02-28 |
| Date Mfgr Received | 2019-01-29 |
| Date Added to Maude | 2018-11-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX, SA |
| Manufacturer Street | 5 RUE DES BERGES |
| Manufacturer City | 38024 GRENOBLE, CEDEX 01 |
| 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 | PPM |
| Date Received | 2018-11-08 |
| Catalog Number | 280134 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 38024 GRENOBLE, CEDEX 01 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-08 |