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 2018-07-11 for CHROMID? MRSA AGAR 43459 manufactured by Biom?rieux Sa.
[114023982]
A customer in (b)(6) contacted biom? Rieux to report the occurrence of a false positive result in association with chromid? Mrsa agar (reference 43459, lot 1006377250). The false positive results were reported by the customer to biom? Rieux on (b)(6) 2018. The product expiration was june 5, 2018. The customer stated there was a delay of three (3) days due the need for retesting of the specimen. The customer indicated there was no incorrect result reported to the treating physician, and there was no adverse impact to the patient's state of health due to the discrepant chromid mrsa results. Although product reference 43459 is not sold/registered in the united states, a similar product (reference 43451 - chromid mrsa agar) is sold in the united states. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00105 |
| MDR Report Key | 7677668 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-07-11 |
| Date of Report | 2018-10-02 |
| Date Mfgr Received | 2018-09-13 |
| Device Manufacturer Date | 2018-03-20 |
| Date Added to Maude | 2018-07-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. JEFF SCANLAN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318694 |
| Manufacturer G1 | BIOM |
| Manufacturer Street | 5 RUE DES AQUEDUCS 69290 CRAPONNE |
| Manufacturer Country | FR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHROMID? MRSA AGAR |
| Generic Name | CHROMID? MRSA AGAR |
| Product Code | JSO |
| Date Received | 2018-07-11 |
| Catalog Number | 43459 |
| Lot Number | 1006377250 |
| Device Expiration Date | 2018-06-05 |
| 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 69290 CRAPONNE FR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-11 |