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 2018-07-06 for EASYMAG? INSTRUMENT 200111 manufactured by Biomerieux Sa.
[113338466]
A customer in sweden notified biom? Rieux of a false positive result associated with easymag? Instrument (reference 200111). The customer reported when they extracted patient samples that have high concentrations of norovirus they are seeing some contaminations in later samples run on the easymag? Instrument. The end result is a false positive result for norovirus. Due to the false positive result there is a 24 hour delay in reporting to the physician. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00099 |
| MDR Report Key | 7666909 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-06 |
| Date of Report | 2018-10-24 |
| Date Mfgr Received | 2018-09-26 |
| Date Added to Maude | 2018-07-06 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. TIFFANY HALL |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | VIA DI CAMPIGLIANO 58 - LOC. PONTE A EMA |
| Manufacturer City | 50012 BAGNO A RIPOLI, |
| Manufacturer Country | IT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EASYMAG? INSTRUMENT |
| Generic Name | EASYMAG? INSTRUMENT |
| Product Code | JJH |
| Date Received | 2018-07-06 |
| Model Number | 200111 |
| 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 | VIA DI CAMPIGLIANO 58 - LOC. PONTE A EMA 50012 BAGNO A RIPOLI, IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-06 |