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 2016-05-19 for CHROMID? S AUREUS AGAR 43371 manufactured by Biomerieux Sa.
[45527271]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[45527272]
A customer in france notified biom? Rieux of a discrepant result associated with chromid? S. Aureus agar (reference (b)(4)). The customer reported an absence of growth for a s. Aureus strain after 48 hours of incubation. The strain was isolated on cos anc media. The customer indicated that the false result was not reported to a physician; however, the result was delayed for 24 hours. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[46134770]
A customer in (b)(6) notified biom? Rieux of a discrepant result associated with chromid s. Aureus agar (reference 43371) involving absence of growth for a s. Aureus strain after 48 hours of incubation. An internal biom? Rieux investigation was performed with results as follows: retention sample of customer's lot (1004624450) and two random lots (1004639390/same manufacturing date and 1004875030/recent manufacture date) were tested with strains s. Aureus atcc 25923, s. Aureus atcc 6538, s. Xylosus atcc 29971 and s. Saprophyticus atcc 15305. Results- after 18-24 hour incubation at 33-37? C, the performance was within specifications for all strains without differences between lots regarding: numeration, size of colony and intensity of color. S. Aureus atcc 25923 and s. Aureus atcc 6538 produced the expected colony appearance. Both developed a spontaneous green coloration whereas, s. Xylosus atcc 29971 and s. Saprophyticus atcc 15305 were not able to produce glucosidase activity. Complaint trending was reviewed; no critical issues regarding product performance were detected. Review of raw data related to manufacturing process and quality control steps was performed. All specifications met and no observations or non-conformities found that could explain the performance problem reported by the customer. Biom? Rieux requested the strain from the customer; however, it was not possible to submit the strain. Based upon the results of the internal investigation, chromid s. Aureus agar is performing in accordance with product specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00090 |
| MDR Report Key | 5667095 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-05-19 |
| Date of Report | 2016-05-12 |
| Date Mfgr Received | 2016-05-12 |
| Date Added to Maude | 2016-05-19 |
| 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 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID? S AUREUS AGAR |
| Generic Name | CHROMID? S AUREUS AGAR |
| Product Code | JWX |
| Date Received | 2016-05-19 |
| Catalog Number | 43371 |
| Lot Number | 1004624450 |
| Device Expiration Date | 2016-05-23 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2016-05-19 |