MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-26 for CHROMID(TM) CARBA AGAR 20 PLT 43861 manufactured by Biomerieux Sa.
[29974328]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[29974332]
Summary: a customer in italy reported a selectivity issue with the chromid carba agar (carb) (b)(4), lot 1004183450 exp. 12oct2015. The customer reported 3 different patient rectal swab samples tested using chomid carba agar, lot 1004183450, were observed to have growth of e. Coli; for patient 1. Klebsiella, for patient 2. A mix of enterococcus and candida for patient 3. Customer reported that all the strains from these three patients were confirmed to not be carbapenemase producing enterobacteriaceae (cpe) (by molecular tests from an external lab) and therefore the strains should not have grown on the carb plates. No wrong results have been reported however, customer reported some results have been delayed 48h. No patient was harmed as consequence of the reported event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2015-00128 |
| MDR Report Key | 5177172 |
| Date Received | 2015-10-26 |
| Date of Report | 2015-10-07 |
| Date Mfgr Received | 2015-10-07 |
| Device Manufacturer Date | 2015-07-28 |
| Date Added to Maude | 2015-10-26 |
| 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 | 0 |
| Brand Name | CHROMID(TM) CARBA AGAR 20 PLT |
| Generic Name | CHROMID(TM) CARBA AGAR 20 PLT |
| Product Code | JSI |
| Date Received | 2015-10-26 |
| Catalog Number | 43861 |
| Lot Number | 1004183450 |
| Device Expiration Date | 2015-10-12 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2015-10-26 |