MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-05 for CHROMID (TM) SA 43371 manufactured by Biomerieux Sa.
[27857509]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[27857510]
Customer called to report weak growth of staphylococcus aureus strain on chromid(tm) staphylococcus aureus, ref. (b)(4), lot 1004235150. Colonies were yellow with no change after 24 hours incubation (green is expected). Customer retested strain with (s. Aureus atcc 25923 tm) and received the same results. No incorrect results were provided to physicians as they use a second method (latex and coagulase) to confirm results.
Patient Sequence No: 1, Text Type: D, B5
[34039674]
Biom? Rieux investigation was conducted in association with chromid tm s. Aureus agar, due to false negative result. Evaluation of the batch records for the implicated lot indicate no discrepancies detected during manufacturing. The results of microbiological quality control were in accordance with specifications. Investigational testing activities included: customer batch of chromid tm s. Aureus agar. Random batch of chromid tm s. Aureus agar. Same strains used during the release tests for the batch. After an incubation of 20-24h, the s. Aureus strain atcc 6538 presents dark green colonies (positive for s. Aureus), with the same results for each batch. The s. Aureus strain atcc 25923 presents green colonies in the mass, but some isolated colonies are pale green to colorless for the random batch and colorless for the customer batch. After an incubation of 48h all the results are correct for each batch: good growth of staphylococcus aureus atcc 25923 with characteristic green colonies. Good growth of staphylococcus aureus atcc 6538 with characteristic green colonies. The investigation concluded that the performance of chromid tm s. Aureus agar (b)(4) is within specifications. The issue reported by the customer could not be duplicated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00112 |
| MDR Report Key | 5126994 |
| Date Received | 2015-10-05 |
| Date of Report | 2015-09-15 |
| Date Mfgr Received | 2015-09-15 |
| Date Added to Maude | 2015-10-05 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| 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) SA |
| Generic Name | CHROMID(TM) SA |
| Product Code | JWX |
| Date Received | 2015-10-05 |
| Catalog Number | 43371 |
| Lot Number | 1004235150 |
| Device Expiration Date | 2015-12-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-10-05 |