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 2018-05-17 for VITEK? 2 ANC TEST KIT 21347 manufactured by Biomerieux Inc..
[109368633]
A customer from italy reported a misidentification of a clostridium sporogenes (atcc? 11437) internal quality control strain as low discrimination organism in association with the vitek? 2 anc test kit. The customer stated that the anc card gave a low discrimination organism result five times. The customer had performed one qc which was compliant. The customer used cba medium for 24 hours then subcultured and inoculated the strain on anc cards. The gram stain was gram positive bacilli. The customer had cleaned the optics and the vitek system did not give any errors. There was no patient involvement as the event pertained to a quality control strain. The instructions for use (ref. 043907-02), indicates the atcc 11437 c. Sporogenes strain is not recommended for anc cards. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00188 |
| MDR Report Key | 7522627 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-05-17 |
| Date of Report | 2018-09-04 |
| Date Mfgr Received | 2018-08-07 |
| Device Manufacturer Date | 2017-01-05 |
| Date Added to Maude | 2018-05-17 |
| 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 | MS. DEBRA BROYLES |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX INC. |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITEK? 2 ANC TEST KIT |
| Generic Name | VITEK? 2 ANC TEST KIT |
| Product Code | JSP |
| Date Received | 2018-05-17 |
| Catalog Number | 21347 |
| Lot Number | 2440223403 |
| Device Expiration Date | 2018-07-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX INC. |
| Manufacturer Address | 595 ANGLUM ROAD ST. LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-17 |