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 2018-01-03 for CHROMID? S. AUREUS ELITE 419042 manufactured by Biom?rieux Espa?a.
[97411749]
A customer from (b)(6) reported to biom? Rieux a false negative result for a (b)(6) strain on a chromid? S. Aureus elite (lot 1005950070) plate. The customer stated a specific strain of staphylococcus aureus did not grow on the chromid? S. Aureus elite plate. The strain was cultured on chromid? S. Aureus elite, chromid? (b)(6) smart, and blood agar. The s. Aureus only grew on the blood agar. The customer then performed disc testing and found the strain to be cefoxitin resistant. It was then cultured from the original sample tube to a new s. Aureus elite plate and a (b)(6) smart plate, and there was no growth on either plate. 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 | 3002769706-2018-00003 |
| MDR Report Key | 7162306 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-03 |
| Date of Report | 2018-04-05 |
| Date Mfgr Received | 2018-03-13 |
| Device Manufacturer Date | 2017-09-07 |
| Date Added to Maude | 2018-01-03 |
| 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 | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | ISAAC NEWTON, 6 TRES CANTOS |
| Manufacturer City | MADRID, SPAIN 28760 |
| Manufacturer Country | SP |
| Manufacturer Postal Code | 28760 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID? S. AUREUS ELITE |
| Generic Name | CHROMID? S. AUREUS ELITE |
| Product Code | JSI |
| Date Received | 2018-01-03 |
| Catalog Number | 419042 |
| Lot Number | 1005950070 |
| ID Number | 03573026494445 |
| Device Expiration Date | 2017-12-25 |
| 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 ESPA?A |
| Manufacturer Address | ISAAC NEWTON, 6 TRES CANTOS MADRID, SPAIN 28760 SP 28760 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-03 |