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 2016-03-28 for CHROMI(TM) OXA 414011 manufactured by Biom?rieux Sa.
[41264349]
A customer in (b)(6) reported a false susceptible result of klebsiella pneumonia oxa 232 on 3 lots while using; chromid(tm) oxa. The customer repeated the test on three times with the same result; a growth on chromid(tm) esbl but no growth on chromid(tm) oxa 48 20 plts. The final two tests were performed with an enrichment with 2 discs and obtained the same result of; esbl: positive, oxa: negative. This klebsiella pneumonia strain was confirmed as resistant to temocillin (mic=384 micro-g/ml). This strain was identified as; klebsiella pneumoniae oxa 232. There were no reports of patient harm or delay in results.
Patient Sequence No: 1, Text Type: D, B5
[50137324]
A customer in (b)(6) reported a false susceptible result of klebsiella pneumonia oxa 232 on 3 lots while using chromid? Oxa. An internal biom? Rieux investigation was performed. Results are as follows: false negative result with the customer strain klebsiella pneumonia as on two (2) other lots close to the same expiration date(13 weeks). The result is well positive on lots more recent(=1024 including the macro colonies in the inhibition zone. There was also an ellipse observed to 256mg/l so the expression of the resistance was heterogeneous. Complaint history: complaint history was reviewed with no trends noted. In conclusion, the false negative result is duplicated in-house and the media chromid? Oxa 48 lot 1004624570 and 1004554440. The sensitivity of this medium has been fixed at 95% (see package insert). This is isolated issue. The device is operating within product limitations (sensitivity 95%).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00061 |
| MDR Report Key | 5529025 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-03-28 |
| Date of Report | 2016-03-22 |
| Date Mfgr Received | 2016-03-22 |
| Device Manufacturer Date | 2016-01-04 |
| Date Added to Maude | 2016-03-28 |
| 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 | MR. JONATHAN NONNEMACHER |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| Manufacturer Phone | 9196203396 |
| 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 | CHROMI(TM) OXA |
| Generic Name | CHROMI(TM) OXA |
| Product Code | JXA |
| Date Received | 2016-03-28 |
| Catalog Number | 414011 |
| Lot Number | 1004554440 |
| Device Expiration Date | 2016-04-09 |
| 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 | 2016-03-28 |