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 2018-08-31 for EMAG? 418591 manufactured by Biomerieux Italia S.p.a..
[119660010]
A customer from (b)(6) reported that they observed droplets of blood samples in the emag? System. The customer observed the droplets on the sample rack and on the reagent rack. The customer reported that droplets have been seen only in the right section (a) of the emag system, where the customer only analyzed whole blood samples. In the left section (b), the customer analyzed other non-blood samples, and could not determine if the issue affected the left section. The customer suspected the issue was related to the pipettor. The customer reported that all patient results were checked after observing the issue and were negative. They were not sure how long the issue existed, so they could not exclude false positive results that may have been reported. 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. Biom? Rieux advise the customer to verify their rack handling/insertion technique, and the customer confirmed that they follow biom? Rieux recommendations. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00176 |
| MDR Report Key | 7836929 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-31 |
| Date of Report | 2018-10-31 |
| Date Mfgr Received | 2018-10-05 |
| Date Added to Maude | 2018-08-31 |
| 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 | MR. JEFF SCANLAN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318694 |
| 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? |
| Generic Name | EMAG? |
| Product Code | JJH |
| Date Received | 2018-08-31 |
| 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. P 50012 BAGNO A RIPOLI FIRENZE, IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-08-31 |