MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-01-31 for NUCLISENS? MAGNETIC SILICA 280133 manufactured by Biom?rieux Sa.
[99001942]
An investigation was performed. Many experiments were performed on (b)(6) applications which did not reproduce the issue. Several silica batches were tested: z018ek1ms, z018cd1ms and z018fl1ms for (b)(6) application and z018ek1ms, z017kg1ms and z018fl1ms for (b)(6) application. An additional (b)(6) application (b)(6) was also tested in order to mimic the ic structure. There was no significant difference observed on ic ct between silica batches. The impact of the sample volume was tested: 200 ul of plasma (as claimed for most of the validated biomerieux's downstream applications) versus 1 ml (as used in the customer's test) were extracted. No significant difference was observed between silica batches on positive and/ or internal controls, whatever the sample input volume tested. The silica batch z018ek1ms conformed with (b)(6) applications. Moreover, real time stability testing was performed on one representative batch of silica from each lot (made from the same raw materials). The nucl. Magn. Silica 384t batch z018ek1ms was made from the same raw material as the silica batch z018eh1ms. All the tests performed on this reference batch, including rna applications (flu and mengo targets), conformed to specifications. The nuclisens? Magnetic silica 384t (lot z018ek1ms) performed within specifications.
Patient Sequence No: 1, Text Type: N, H10
[99001943]
A customer from the united states reported a performance problem with internal control samples in association with nuclisens? Magnetic silica (lot z018ek1ms), when testing (b)(6) on plasma. The customer stated that as they started using lot z018ek1ms on (b)(6) 2017, almost half of the internal control samples started to have higher ct values (34 and 35) than normal. The customer reported that the generic protocol was used and the internal control was a (b)(6) in the (b)(6) family. The customer started they had to extract less sample (200ul instead of the normal 900ul) in order to have the internal control work appropriately. As a result, the sensitivity of the assay to detect (b)(6) decreased, so there was a possibility they missed detecting (b)(6), as patients infected with (b)(6) have very low amounts of (b)(6) present in their plasma. The customer stated that no wrong results were reported to the physician, as they repeated the sample until the internal control was within range. The patient reports included the volume of sample tested and the limits of detection with different sample volumes. The customer reported there were delays for reporting results as they had to repeat many runs (using lower sample volumes) to get the internal control values within range. There is no indication or report from the hospital or treating physician to biom? Rieux that the issue led to any adverse event related to any patient's state of health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00010 |
| MDR Report Key | 7231392 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-31 |
| Date of Report | 2018-01-31 |
| Date of Event | 2017-09-06 |
| Date Mfgr Received | 2017-11-07 |
| Device Manufacturer Date | 2017-06-23 |
| Date Added to Maude | 2018-01-31 |
| 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 |
| Generic Name | NUCLISENS? MAGNETIC SILICA |
| Product Code | LDT |
| Date Received | 2018-01-31 |
| Catalog Number | 280133 |
| Lot Number | Z018EK1MS |
| ID Number | 03573026139339 |
| Device Expiration Date | 2018-05-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2018-01-31 |