MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-10 for NUCLISENS? LYSIS BUFFER 200292 manufactured by Biomerieux S.a..
[123848702]
A customer in (b)(6) reported a performance problem with nuclisens? Lysis buffer (lot 17110901) when testing patient stool specimens by rt-pcr inhibitors (enterovirus r-gene). The customer stated they obtained abnormally high results with buffer lot 17110901, as there was 27% inhibition detected in the samples. Results with other lots were 3% and 4%. The customer performed an investigation with different lots of lysis buffer and determined there was a problem with lot 17110901. The customer reported that no incorrect result was reported to a physician and the patient treatment was not impacted. There was a delay as samples had to be re-extracted. Biom? Rieux requested the customer's extraction protocol for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00206 |
| MDR Report Key | 7951961 |
| Date Received | 2018-10-10 |
| Date of Report | 2018-12-27 |
| Date Mfgr Received | 2018-11-30 |
| Device Manufacturer Date | 2017-11-09 |
| Date Added to Maude | 2018-10-10 |
| 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 |
| 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 S.A. |
| Manufacturer Street | 5 RUE DES AQUEDUCS |
| Manufacturer City | CRAPONNE, 69290 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69290 |
| 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 |
| Date Received | 2018-10-10 |
| Catalog Number | 200292 |
| Lot Number | 17110901 |
| Device Expiration Date | 2019-10-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX S.A. |
| Manufacturer Address | 5 RUE DES AQUEDUCS CRAPONNE, 69290 FR 69290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-10 |