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 2019-01-15 for NUCLISENS? MAGNETIC SILICA 280133 manufactured by Biomerieux, Sa.
[134925691]
A customer in the united states reported a performance problem with nuclisens? Magnetic silica when extracting urine samples on the easymag? Instrument for two patients (a & b). The customer stated that results for the same patient when tested at different volumes, gave really different results downstream. The downstream application was run as a quantitative assay for bk virus. The customer ran the test on patient a in duplicate. The extraction was performed two different ways, they first ran the urine in duplicate for a volume of 500 ul with an eluate of 60ul and the second was 200 ul with an eluate of 50 ul. Downstream for bk virus they recovered a result of 4. 3 million for the sample that had 500 ul volume and they obtained 26000 for the 200 ul volume sample. For patient b the customer also ran this in duplicate and they reported that they first ran the urine in duplicate for a volume of 500 ul with an eluate of 60 ul and the second was 200 ul with an eluate of 50 ul. Downstream for bk virus they recovered a result of 8,000 for the sample that had 500 ul volume and they obtained 763,000 for the 200 ul volume sample. The customer reported that samples for patient a and b were sent to a reference lab at 3-4 days for results to be reported out. There was no wrong result reported to a physician, and the patient treatment was not impacted. 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 | 3008249922-2019-00002 |
| MDR Report Key | 8248577 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-15 |
| Date of Report | 2019-03-19 |
| Date Mfgr Received | 2019-02-20 |
| Date Added to Maude | 2019-01-15 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX, SA |
| Manufacturer Street | 5 RUE DES BERGES |
| Manufacturer City | 38024 GRENOBLE, CEDEX 01 |
| Manufacturer Country | FR |
| 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 | PPM |
| Date Received | 2019-01-15 |
| Catalog Number | 280133 |
| Lot Number | Z019FE1MS |
| Device Expiration Date | 2019-06-28 |
| 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 38024 GRENOBLE, CEDEX 01 FR |
| Brand Name | NUCLISENS? MAGNETIC SILICA |
| Generic Name | NUCLISENS? MAGNETIC SILICA |
| Product Code | LTD |
| Date Received | 2019-01-15 |
| Catalog Number | 280133 |
| Lot Number | Z019FE1MS |
| 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 38024 GRENOBLE, CEDEX 01 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-15 |