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 2017-11-20 for CHROMID? MRSA SMART 413050 manufactured by Biomerieux Sa.
[93480605]
A customer in poland notified biom? Rieux of a false positive associated with chromid? (b)(6). The customer reported receiving the (b)(6) smart medium growth of control strain s. Aureus (b)(6) atcc 43300 and two (2) (b)(6) strains on (b)(6) 2017. The medium was stored in accordance with the package insert at 2-8? C in the dark. The plates were exposed to light only for inoculation and reading. Repeat testing was completed on (b)(6) 2017 the test with the same strains on a different medium (b)(6) elite lot 1005970640 and received correct result - for control strain (b)(6) - growth, for (b)(6) strains - no growth. The (b)(6) strains were confirmed by various methods; disc diffusion method, vitek? 2, (b)(6) detection test for pbp2 protein with a negative result. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00377 |
| MDR Report Key | 7044825 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-20 |
| Date of Report | 2018-05-17 |
| Date Mfgr Received | 2018-04-27 |
| Device Manufacturer Date | 2017-09-08 |
| Date Added to Maude | 2017-11-20 |
| 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. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | 5, RUE DES AQUEDUCS CRAPONNE, FR 69290 |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID? MRSA SMART |
| Generic Name | CHROMID? MRSA SMART |
| Product Code | JSO |
| Date Received | 2017-11-20 |
| Catalog Number | 413050 |
| Lot Number | 1005950400 |
| Device Expiration Date | 2017-11-17 |
| 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, FR 69290 FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-20 |