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 2015-11-16 for CHROMID(TM) CPS ELITE 416172 manufactured by Biomerieux Sa.
[31334666]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[31334667]
A customer called on (b)(6) 2015 to report when using chromid cps elite, (b)(4), lot 0351 8563202, exp. Date jan 06, 2016 the agar fell into the lid. Customer stated one patient test result was effected, no patient harm but there was a delay in reporting the results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2015-00145 |
| MDR Report Key | 5225334 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-11-16 |
| Date of Report | 2015-11-05 |
| Date Mfgr Received | 2015-11-05 |
| Device Manufacturer Date | 2015-09-10 |
| Date Added to Maude | 2015-11-16 |
| 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 | MR. RYAN LEMELLE |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, RHONE 69280 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID(TM) CPS ELITE |
| Generic Name | CHROMID(TM) CPS ELITE |
| Product Code | JXA |
| Date Received | 2015-11-16 |
| Catalog Number | 416172 |
| Lot Number | 1004285230 |
| Device Expiration Date | 2016-01-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-16 |