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 2015-10-24 for CHROMID(TM) CPS ELITE 418284 manufactured by Biomerieux Sa.
[29213716]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[29213717]
On (b)(6) 2015, a customer from (b)(6) reported an incorrect identification of a bacteria associated with using chromid(tm) cps elite translucen ref. 418284, lot 1004156150 exp. 10-nov-2015. The customer observed pink isolates on cpse agar, which according to the instructions for use would indicate presence of escherichia coli. The customer performed an antibiogram test and obtained a suspected result for carbapenemase. Therefore, the customer sent the strain to the reference lab to confirm the carbapenemase producing indicator. The reference lab identified the strain as hafnia alvei bacteria and excluded the carbapenemase producing indicator. The customer performed additional identification tests from isolates on cpse agar and cos agar (lot not provided): identification of hafnia alvei bacteria was confirmed. The customer did not provide the confirmation results to the physician, the false identification for escherichia coli was reported to the physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2015-00127 |
| MDR Report Key | 5173190 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-10-24 |
| Date of Report | 2015-10-01 |
| Date Mfgr Received | 2015-10-01 |
| Device Manufacturer Date | 2015-07-15 |
| Date Added to Maude | 2015-10-24 |
| 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 | 2015-10-24 |
| Catalog Number | 418284 |
| Lot Number | 1004156150 |
| Device Expiration Date | 2015-11-10 |
| 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 | 2015-10-24 |