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 2016-11-11 for NUCLISENS? EASYMAG? MAGNETIC SILICA 280133 manufactured by Biom?rieux Sa.
[59842789]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[59842790]
A customer in the united states contacted biom? Rieux to report downstream performance issues associated with the nuclisens? Easymag? Magnetic silica product. The customer uses focus diagnostics integrated cycler (real-time pcr) with their simplexa reagents to detect epstein barr virus (ebv). The customer stated that they were unable to detect the lower concentration ebv in a cap survey sample, which constitutes a false negative result. Their nucleic acid target is double stranded, and of medium genome size. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. There was no patient directly associated with the cap survey sample. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[68162336]
The customer stated that they were unable to detect the lower viral load ebv (vls2-15 sample) for a cap survey sample using nuclisens? Easymag? Magnetic silica product. A biomerieux internal investigation was conducted. For the cap survey the customer performed 4 different pcr amplifications : adenovirus, bk, cmv and ebv. All of the obtained results were within the expected range, except the one sample for ebv. The customer had two cap samples tested for ebv viral load, using the focus diagnostics integrated cycler (real-time pcr) with their simplexa reagents: o vls2-16 sample : the result was within the expected range (3. 6 iu/ml for a calculated mean of 3. 717 iu/ml for the focus diagnostics users and of 3. 633 iu/ml for all methods). O vls2-15 sample : the result was: < 2. 89 iu/ml (not detected). For this sample, "173 results would be reported as: 128 positive results and 45 not detected results. " the mean obtained by all the participants is 2. 558 iu/ml (log10), which is below the detection limit of the used technology, ie 2. 89 iu/ml. The customer obtained a "negative" result like 26% of all cap participants. Therefore, this cap sample seems to have a concentration below the lowest reportable quantity limit of 2. 89 iu/ml fixed by the ebv amplification method used by the customer. The investigation concluded that the negative result obtained by the customer for vls2-15 sample is linked to the sensitivity of the method used. The mean value obtained for this sample is 2. 558 iu/ml, which is below the lowest reportable quantity limit of 2. 89 iu/ml fixed by the ebv amplification method used. The nuclisens? Easymag? Magnetic silica product is therefore not the root cause of this event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00472 |
| MDR Report Key | 6095813 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-11-11 |
| Date of Report | 2017-02-20 |
| Date Mfgr Received | 2017-01-24 |
| Date Added to Maude | 2016-11-11 |
| 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 | HAZELWOOD 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? EASYMAG? MAGNETIC SILICA |
| Generic Name | NUCLISENS? EASYMAG? MAGNETIC SILICA |
| Product Code | LDT |
| Date Received | 2016-11-11 |
| Catalog Number | 280133 |
| Lot Number | Z017KF1MS |
| Device Expiration Date | 2017-09-28 |
| 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 | 2016-11-11 |