MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-14 for NUCLISENS? MAGNETIC SILICA 280133 manufactured by Biomerieux Sa.
[102914960]
A customer in (b)(6) reported a performance problem with nuclisens? Magnetic silica (lot z018gb1ms). The customer reported experiencing inhibition/ low recovery of internal controls (pdv and phhv viruses) on three easymag? Systems. They noticed higher cts on their internal controls. Decontamination provided no improvement. The customer indicated that the silica batch pipets differently than usual. The customer uses the generic extraction protocol stool specific a. Sample types tested are mainly stool, but also swabs and sputa. The customer stated that reported patients results were possibly affected as results with decreased sensitivities were produced during this period of time. The customer stated that sometimes there was an unexpected delay in reporting results because several runs were repeated due to the decreased sensitivity. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00040 |
| MDR Report Key | 7339176 |
| Date Received | 2018-03-14 |
| Date of Report | 2018-05-18 |
| Date Mfgr Received | 2018-04-24 |
| Device Manufacturer Date | 2017-02-03 |
| Date Added to Maude | 2018-03-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | 5, RUE DES BERGES |
| Manufacturer City | GRENOBLE CEDEX 01, 38024 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 38024 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NUCLISENS? MAGNETIC SILICA |
| Generic Name | NUCLISENS? MAGNETIC SILICA |
| Product Code | PPM |
| Date Received | 2018-03-14 |
| Catalog Number | 280133 |
| Lot Number | Z018GB1MS |
| Device Expiration Date | 2018-07-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | 5, RUE DES BERGES GRENOBLE CEDEX 01, 38024 FR 38024 |
| Brand Name | NUCLISENS? MAGNETIC SILICA |
| Generic Name | NUCLISENS? MAGNETIC SILICA |
| Product Code | LTD |
| Date Received | 2018-03-14 |
| Catalog Number | 280133 |
| Lot Number | Z018GB1MS |
| Device Expiration Date | 2018-07-28 |
| 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 GRENOBLE CEDEX 01, 38024 FR 38024 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-14 |