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 2017-07-28 for CHROMID? MRSA 43451 manufactured by Biom?rieux Sa.
[81362444]
A customer from (b)(6) reported to biom? Rieux a false positive (b)(6) result for a multi-resistant patient isolate in association with chromid? (b)(6) 20 plt. The customer reported the (b)(6) isolate was cultured on the chromid? (b)(6) and the isolate grew only the (b)(6) lot. The customer reported patient results were affected as infection control acts on presumptive positives that are green on chromid? Agar. The patient was isolated with other colonized (b)(6) positive patients due to this result and was possibly exposed to truly positive (b)(6) patients. The customer stated there was a delay in reporting results as sensitivity testing and further testing had to be performed due to the discrepancy. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2017-00211 |
| MDR Report Key | 6751003 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-28 |
| Date of Report | 2017-11-21 |
| Date Mfgr Received | 2017-10-31 |
| Device Manufacturer Date | 2017-04-14 |
| Date Added to Maude | 2017-07-28 |
| 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 | 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? MRSA |
| Generic Name | CHROMID? MRSA |
| Product Code | JSO |
| Date Received | 2017-07-28 |
| Catalog Number | 43451 |
| Lot Number | 1005639900 |
| ID Number | 03573026136642 |
| Device Expiration Date | 2017-06-30 |
| 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 | 1. Required No Informationntervention | 2017-07-28 |