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 2018-06-28 for CHROMID? CPS AGAR 35131 manufactured by Biomerieux Sa.
[113008958]
A customer from (b)(6) reported contamination of 30 plates of chromid? Cps (lot 1006334210). The customer reported that after plate incubation for 18-24 hours at 37? C, fungus growth was observed which inhibited other microorganisms and results. The customer stated they followed the manufacturer's recommended transportation and storage conditions. The customer stated that no incorrect result was reported to a physician and patients were not impacted. There was a delay of 48 hours for retesting and reporting results. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00090 |
| MDR Report Key | 7647987 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-28 |
| Date of Report | 2018-08-13 |
| Date Mfgr Received | 2018-07-15 |
| Device Manufacturer Date | 2018-03-05 |
| Date Added to Maude | 2018-06-28 |
| 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 | MS. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318805 |
| Manufacturer G1 | BIOMERIEUX SA |
| 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 AGAR |
| Generic Name | CHROMID? CPS AGAR |
| Product Code | JXA |
| Date Received | 2018-06-28 |
| Catalog Number | 35131 |
| Lot Number | 1006334210 |
| Device Expiration Date | 2018-07-02 |
| 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 SA |
| Manufacturer Address | 5 RUE DES AQUEDUCS CRAPONNE, 69290 FR 69290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-28 |