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 2018-01-24 for CHROMID? CARBA 43861 manufactured by Biom?rieux Sa.
[98167128]
A customer from (b)(6) reported a false positive carbapenemase for an escherichia coli isolate with the chromid? Carba agar (lot 1006075040). The customer reported the chromid carba result was a pink colony. The result of vitek? 2 ast-n211 card was ertapenem mic <=0. 25, meropenem mic <=0. 25 s (no imipenem mic test). The customer subcultured the pick colony on both chromid carba and bap media. The customer observed that the sample grew very well with the typical color. The customer performed carba np test and genexpert kpc with the colony on the bap. The results were a weak positive in rapidec carba np and negative in gene xpert. The customer finalized testing as negative. The customer reported that the isolate was detected by the active surveillance culture, so it did not affect patient medication treatment; however, the patient was unnecessarily put into isolation due to the results. According to the lab protocol, the false positive carbapenemase was reported to the physician and then the patient was isolated prior to confirmation testing of pcr, rapidec carba np, and vitek 2. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any physical 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 | 3002769706-2018-00009 |
| MDR Report Key | 7217130 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-01-24 |
| Date of Report | 2018-04-05 |
| Date Mfgr Received | 2018-03-16 |
| Device Manufacturer Date | 2017-11-07 |
| Date Added to Maude | 2018-01-24 |
| 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? CARBA |
| Generic Name | CHROMID? CARBA |
| Product Code | JSI |
| Date Received | 2018-01-24 |
| Catalog Number | 43861 |
| Lot Number | 1006075040 |
| ID Number | 03573026316952 |
| Device Expiration Date | 2018-01-22 |
| 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. Other | 2018-01-24 |