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 2018-10-29 for VITEK? 2 GP ID TEST KIT 21342 manufactured by Biomerieux, Inc..
[126662448]
A customer in (b)(6) reported a misidentification of staphylococcus lugdunensis as leuconostoc mesenteroides for two patient isolates with the vitek? 2 gp id test kit. On (b)(6) 2018, the gp card identified leuconostoc mesenteroides and the isolates were confirmed as staphylococcus lugdunensis by maldi-tof. The customer reported that the vitek result was not reported to a physician and patient care was not impacted. The local field application specialist (fas) went to the site and retested the isolates and the identification was staphylococcus lentus (99%). The fas then tested a fresh isolate at a different customer site and the identification was staphylococcus lugdonensis (99%). The customer performed repeat testing on the two isolates on their three vitek instruments. Isolate (b)(4) was identified as staphylococcus lentus on all three instruments. Isolate (b)(4) had one identification as staphylococcus lentus and two as staphylococcus lugdonensis. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00450 |
| MDR Report Key | 8017119 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-10-29 |
| Date of Report | 2019-01-15 |
| Date of Event | 2018-09-30 |
| Date Mfgr Received | 2018-12-18 |
| Date Added to Maude | 2018-10-29 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 G1 | BIOMERIEUX, INC. |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD 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 GP ID TEST KIT |
| Generic Name | VITEK? 2 GP ID TEST KIT |
| Product Code | LQL |
| Date Received | 2018-10-29 |
| Catalog Number | 21342 |
| Lot Number | 2420735203 |
| Device Expiration Date | 2019-12-01 |
| 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 HAZELWOOD MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-29 |