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 2018-05-29 for EMAG? 418591 manufactured by Biomerieux Italia S.p.a..
[109515359]
A customer in (b)(6) previously reported that they had the presence of crystallization on the distribution nozzles of the emag? Instrument (ref (b)(4)). The customer reported that there were blood crystals on this nozzle resulting in potential specimen contamination. After performing the cleaning as described by the user manual, a period of time had passed and the same issue was reported again. This time the customer observed one aspirator that was sunk on the distribution nozzles of the emag? Instrument, and drops of buffer/eluate were observed on the vessel caps at the end of a run. The customer stated there was no instrument error but they could not dispense samples because they did not have enough eluate volume for four parameters. It was not known if testing was repeated on the impacted samples. 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. The field service engineer (fse) replaced the dispensing needles, and the elutions were performed correctly. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00071 |
| MDR Report Key | 7549621 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-29 |
| Date of Report | 2018-10-16 |
| Date Mfgr Received | 2018-09-17 |
| Date Added to Maude | 2018-05-29 |
| 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 | MS. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX ITALIA S.P.A. |
| 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 | EMAG? |
| Generic Name | EMAG? |
| Product Code | JJH |
| Date Received | 2018-05-29 |
| Model Number | 418591 |
| 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 ITALIA S.P.A. |
| Manufacturer Address | VIA DI CAMPIGLIANO 58 - LOC. PONTE A EMA 50012 BAGNO A RIPOLI, IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-29 |