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 2018-11-12 for CHROMID? CPS ELITE 416172 manufactured by Biomerieux S.a..
[129156685]
A customer in the (b)(6) reported a no result (no growth) for an external quality control (eqa) sample (neqas distribution 4341 sample 4569) on chromid? Cps elite agar (lot 1006606560). The expected result of the eqa sample was staphylococcus saprophyticus. When the customer obtained the results of the neqas survey, they asked for a repeat sample. The customer then tested a second lot (100666680) of chromid cps elite, and also cultured the eqa sample onto blood agar and cled (cystine lactose electrolyte deficient) medium. The result was no growth on chromid cps elite, while staphylococcus saprophyticus grew on both blood agar and cled. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00237 |
| MDR Report Key | 8062054 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-11-12 |
| Date of Report | 2018-12-11 |
| Date Mfgr Received | 2018-11-14 |
| Device Manufacturer Date | 2018-06-27 |
| Date Added to Maude | 2018-11-12 |
| 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 | MS. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX S.A. |
| Manufacturer Street | 5 RUE DES AQUEDUCS |
| Manufacturer City | CRAPONNE, 69290 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69290 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID? CPS ELITE |
| Generic Name | CHROMID? CPS ELITE |
| Product Code | JXA |
| Date Received | 2018-11-12 |
| Catalog Number | 416172 |
| Lot Number | 1006666680 |
| Device Expiration Date | 2018-11-18 |
| 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 S.A. |
| Manufacturer Address | 5 RUE DES AQUEDUCS CRAPONNE, 69290 FR 69290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-12 |