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 2017-07-24 for NUCLISENS? LYSIS BUFFER 280134 manufactured by Biomerieux Sa.
[80791208]
A customer in (b)(6) reported to biom? Rieux that they observed yellow colored eluates and inhibition on downstream applications while using nuclisens lysis buffer to extract the nucleic acids. The issue occurred intermittently and the other results for non-colored eluates are under the expected values. The customer spiked the colored eluates with a positive control and the result was inhibited. After re-extraction, a good result was obtained. On the seven (7) blood samples tested, the b globin was only detected on three (3). The customer uses a generic protocol which they have obtained successful results in the past. Since a positive control was used, an incorrect result was not communicated to the physician and no patient was incorrectly treated. However, the customer did report there was a delay greater than a day due to the re-extraction and retest of the impacted samples. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00203 |
| MDR Report Key | 6735453 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-24 |
| Date of Report | 2017-09-19 |
| Date Mfgr Received | 2017-08-25 |
| Device Manufacturer Date | 2017-01-06 |
| Date Added to Maude | 2017-07-24 |
| 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 | MS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | 5, RUE DES BERGES CEDEX 01 |
| Manufacturer City | 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? LYSIS BUFFER |
| Generic Name | NUCLISENS? LYSIS BUFFER |
| Product Code | PPM |
| Date Received | 2017-07-24 |
| Model Number | 280134 |
| Lot Number | Z018NA1LB |
| Device Expiration Date | 2018-12-28 |
| 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 SA |
| Manufacturer Address | 5, RUE DES BERGES CEDEX 01 GRENOBLE, 38024 FR 38024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-24 |