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 2017-10-25 for NUCLISENS? MAGNETIC SILICA 384T 280133 manufactured by Biom?rieux Sa.
[91002014]
A customer from (b)(6) reported to biom? Rieux false negative results for their quality control when using nuclisens? Magnetic silica 384t ( lot z018ek1ms). The customer used an altona pcr kit for hepatitis e virus (hev) amplification/detection from plasma samples, extracted with the biom? Rieux easymag? System. The samples were plasma pools of donor pockets that are then reused for plasma donation. When the customer used a new silica batch (z018ek1ms), they observed an under quantification or false negative results with the quality control (a known hev positive plasma sample) and the value of the internal control (ic) is also higher than expected. The previous silica lot performed without issue. Due to the incorrect qc value out of the expected range, runs could not be validated. Samples were re-extracted with the previous silica lot. There was a delay of one week after the expected timeframe for reporting results. The customer stated that no patient was impacted, as only the customer internal control has been impacted by the issue. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00314 |
| MDR Report Key | 6977876 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-10-25 |
| Date of Report | 2018-01-24 |
| Date Mfgr Received | 2017-12-25 |
| Device Manufacturer Date | 2017-06-23 |
| Date Added to Maude | 2017-10-25 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | 5, RUE DES BERGES |
| Manufacturer City | GRENOBLE CEDEX 01, FR 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? MAGNETIC SILICA 384T |
| Generic Name | NUCLISENS? MAGNETIC SILICA 384T |
| Product Code | LDT |
| Date Received | 2017-10-25 |
| Catalog Number | 280133 |
| Lot Number | Z018EK1MS |
| ID Number | 03573026139339 |
| Device Expiration Date | 2018-05-28 |
| 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 DES BERGES GRENOBLE CEDEX 01, FR 38024 FR 38024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-25 |