MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-27 for CHROMID? CPS ELITE 418284 manufactured by Biomerieux S.a..
[145531421]
A customer in (b)(6) reported no growth (false negative) of an escherichia coli strain from a patient urine sample, in association with the chromid? Cps elite agar (lot 1007058530). The sample was from a (b)(6) year old patient with no antibiotic therapy and inflammatory syndrome and leukocytosis. The customer stated there was no growth on the chromid cps elite agar, but growth was observed on cos + polyvitex agar. The strain was then identified as escherichia coli by vitek? 2. 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. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615755-2019-00003 |
| MDR Report Key | 8458030 |
| Date Received | 2019-03-27 |
| Date of Report | 2019-06-27 |
| Date Mfgr Received | 2019-06-07 |
| Device Manufacturer Date | 2019-01-15 |
| Date Added to Maude | 2019-03-27 |
| 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 Phone | 3145068201 |
| 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 | 0 |
| Brand Name | CHROMID? CPS ELITE |
| Generic Name | CHROMID? CPS ELITE |
| Product Code | JXA |
| Date Received | 2019-03-27 |
| Catalog Number | 418284 |
| Lot Number | 1007058530 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-03-27 |