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 2016-12-29 for NUCLISENS? MAGNETIC SILICA 280133 manufactured by Biom?rieux Sa.
[63614152]
A customer in (b)(6) notified biom? Rieux of a performance decrease for extraction results associated with the nuclisens? Magnetic silica using an input volume of 300? L. The customer reported that patient results were affected, incorrect results were not communicated to a physician, and a patient was not harmed or mistreated. There was a delay for results of approximately 3-4 days. The customer indicated that extractions worked when retesting with magnapure. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[73838485]
An internal biom? Rieux investigation was conducted. Results are as follows: a difference of quantification up to 1 log and sometimes more than 1 log was observed. As the downstream applications are qualitative and/or quantitative, the decrease of performances in downstream application could lead to:? A risk of false negative for qualitative tests,? Invalid results when extracted and amplified internal control is not within specifications,? Under-quantification for viral load results for quantitative tests we have confirmed the issue for the following customer's application specificity:? Impact when using a high sample input volume, from 200? L and up to 1 ml? Impact when double stranded nucleic acid applications with small (<40kbp) and medium genome sizes (
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00534 |
| MDR Report Key | 6212451 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-12-29 |
| Date of Report | 2017-04-10 |
| Date Mfgr Received | 2017-03-14 |
| Date Added to Maude | 2016-12-29 |
| 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 |
| Removal Correction Number | Z-2342-2016 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NUCLISENS? MAGNETIC SILICA |
| Generic Name | NUCLISENS? MAGNETIC SILICA |
| Product Code | LDT |
| Date Received | 2016-12-29 |
| Catalog Number | 280133 |
| Lot Number | Z017MA1MS |
| Device Expiration Date | 2017-11-28 |
| 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 | 2016-12-29 |