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 2018-12-27 for EMAG? INSTRUMENT 418591 manufactured by Biomerieux Italia S.p.a..
[131493285]
A customer in (b)(6) notified biom? Rieux of false negative results associated with emag? (reference 418591). The customer reported obtaining false negative results and thought the sample was just not pipetted, but believed there would have been an error message. There was no error message on the system. 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. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00258 |
| MDR Report Key | 8199083 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-12-27 |
| Date of Report | 2018-12-27 |
| Date Mfgr Received | 2018-11-29 |
| Date Added to Maude | 2018-12-27 |
| 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 ITALIA S.P.A. |
| Manufacturer Street | VIA DI CAMPIGLIANO 58 / LOC. P 50012 BAGNO A RIPOLI |
| Manufacturer City | FIRENZE, |
| Manufacturer Country | IT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMAG? INSTRUMENT |
| Generic Name | EMAG? INSTRUMENT |
| Product Code | JJH |
| Date Received | 2018-12-27 |
| Model Number | 418591 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX ITALIA S.P.A. |
| Manufacturer Address | VIA DI CAMPIGLIANO 58 / LOC. P 50012 BAGNO A RIPOLI FIRENZE, IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-27 |