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 2016-03-29 for CHROMID(TM) CARBA SMART 414685 manufactured by Biom?rieux Sa.
[41425516]
A customer in (b)(6) reported false negative results when using; chromid carba smart. A patient rectal sample was run after admission to the hospital and no growth was observed after incubation. Three days after admission the blood culture of the patient returned positive at (b)(6), the results of the identified as; enterobacter cloacae (carbapenemase positive).
Patient Sequence No: 1, Text Type: D, B5
[47519746]
An investigation into a false negative event while using the chromid? Carba smart test kit was performed. A complaint review for similar reports against on the lot and product number was performed. No systemic issue was identified as part of the trend analysis. Quality control strains were tested on 3 lots of test kits including the lot in question. This testing resulted in numeration, size of colonies and coloration intensity are within specification. The customer returned strain was tested on 5 separate lot of tests, varying over the shelf life of the product. This testing resulted in numeration, size of colonies and coloration intensity are within specification. Based on the results of the investigation, the complaint could not be confirmed and the product is operating within specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00062 |
| MDR Report Key | 5532592 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-29 |
| Date of Report | 2016-03-12 |
| Date Mfgr Received | 2016-03-12 |
| Device Manufacturer Date | 2015-12-21 |
| Date Added to Maude | 2016-03-29 |
| 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 | 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(TM) CARBA SMART |
| Generic Name | CHROMID(TM) CARBA SMART |
| Product Code | JSI |
| Date Received | 2016-03-29 |
| Catalog Number | 414685 |
| Lot Number | 1004537500 |
| Device Expiration Date | 2016-03-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-03-29 |