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 2015-09-11 for CHROMID TM STAPH AUREUS AGAR 43371 manufactured by Biom?rieux Sa.
[25628505]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[25628506]
A customer in (b)(6) reported inconclusive results for the staph aureus atcc strain (indicated in the instructions for use) in association with chromid tm staph aureus agar (ref. 43371, lot 1004085400). Though green colonies are the correct indication for a staph aureus organism, the customer claims the observed light green colony color is not typical compared with the other lot numbers used in the past. Evaluation during the troubleshooting activities by biomerieux support determined the referenced lot number was placed on stop order by biomerieux and is associated with a field corrective action. There is no indication or report from the hospital or treating physician to biomerieux that the inconclusive result led to any adverse event related to a patient's state of health. No patient was directly associated with the atcc strain result. Strain submittals have been requested by biomerieux for internal investigation.
Patient Sequence No: 1, Text Type: D, B5
[41070082]
Biom? Rieux internal investigation was initiated. Evaluation of the qc batch records for the release of chromid tm s aureus agar lot 1004085400 indicates performance in accordance with specifications after 20 hours and 24 hours of incubation at 33-37? C. This lot was the subject of stop shipment ((b)(4), issued 07aug15) and field safety corrective action (fsca-2624, issued 19aug15) due to ingredient discrepancy in the dry environment of the formula used in the manufacture of the lot. This discrepancy can induce slower or weaker staining of s. Aureus strains. Customers were instructed to discard the incriminated product lot. A capa was initiated to determine the root cause of the raw material mixture in the dry environment and define the corrective and preventive actions. Testing was performed on the agar plates submitted by the client. Three (3) staphylococcus aureus strains were tested: atcc 6538 and 13150 gave characteristic colonies at 24 hours, atcc 25923 gave characteristic colonies at 48 hours. The issue described by the customer was not confirmed with the chromid s aureus plates submitted by the customer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2015-00083 |
| MDR Report Key | 5072147 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-09-11 |
| Date of Report | 2015-08-07 |
| Date Mfgr Received | 2015-08-07 |
| Date Added to Maude | 2015-09-11 |
| 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 | BIOM |
| Manufacturer Street | 5, RUE DES AQUEDUCS |
| Manufacturer City | CRAPONNE, FR 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 TM STAPH AUREUS AGAR |
| Generic Name | CHROMID STAPH AUREUS AGAR |
| Product Code | JWX |
| Date Received | 2015-09-11 |
| Catalog Number | 43371 |
| Lot Number | 1004085400 |
| Device Expiration Date | 2015-10-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOM?RIEUX SA |
| Manufacturer Address | 5, RUE DES AQUEDUCS CRAPONNE, FR 69290 FR 69290 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-11 |