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 2018-01-12 for NUCLISENS? MAGNETIC SILICA 280133 manufactured by Biom?rieux Sa.
[97746329]
A customer from the united states reported a performance problem in association with nuclisens? Magnetic silica (lot tz018eh1ms). The customer reported that six (6) of 22 samples failed internal controls on both nuclisens? Easymag? And emag? Instruments. The samples were being tested for (b)(6) from whole blood. The customer also noticed colored eluates with the whole blood as it was a tinged pink color. Retesting with 140 ul of silica gave the same results. The customer stated that when they started using this lot, they stopped using the generic protocol for whole blood samples, and started using the specific b protocol they found online. The customer stated the generic and specific b protocols did not work with this lot. The customer stated that patient samples and (b)(6) results were delayed greater than 24 hours for repeat testing as the extractions were not working. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00008 |
| MDR Report Key | 7186361 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-01-12 |
| Date of Report | 2018-03-22 |
| Date Mfgr Received | 2018-02-27 |
| Device Manufacturer Date | 2017-06-19 |
| Date Added to Maude | 2018-01-12 |
| 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 | 2018-01-12 |
| Catalog Number | 280133 |
| Lot Number | Z018EH1MS |
| 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 | 2018-01-12 |