MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-05-16 for VITEK?2 GP TEST KIT 21342 manufactured by Biomerieux Inc..
[109002157]
A customer in the united states notified biom? Rieux of discrepant results associated with vitek? 2 gp test kit (reference (b)(4)). Customer called in with issues while running listeria innocua and monocytogenes species on their gp cards. Listeria monocytogenes is giving low discrimination on one machine and unidentified. Listeria innocua is identifying listeria welshimeri and unidentified. The customer stated that their last preventative maintenance was in (b)(6) 2017. A new lot of gp cards were run on (b)(6) 2018 and the results were as follows: serial no. (b)(4) = l. Innocua 95% and l. Monocytogenes 95%. Serial no. (b)(4) = l. Welshimeri 90% and l. Monocytogenes 95%. A second run was performed on (b)(6) 2018 and results were as follows: serial no. (b)(4) = six (6) cards were run on this instrument three (3) cards for each species were identified as l. Innocua and l. Monocytogenes serial no. (b)(4) = six (6) cards were run on this instrument, three (3) cards for each species were identified as l. Innocua and l. Monocytogenes there is no patient associated with this case because this complaint comes from an industry customer. An adverse impact was not reported by the customer. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00175 |
| MDR Report Key | 7519365 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-05-16 |
| Date of Report | 2018-08-21 |
| Date Mfgr Received | 2018-07-24 |
| Date Added to Maude | 2018-05-16 |
| 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. TIFFANY HALL |
| Manufacturer Street | 100 RODOLPHE STREET |
| Manufacturer City | DURHAM NC 27712 |
| Manufacturer Country | US |
| Manufacturer Postal | 27712 |
| 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 GP TEST KIT |
| Generic Name | VITEK?2 GP TEST KIT |
| Product Code | LQL |
| Date Received | 2018-05-16 |
| Catalog Number | 21342 |
| Lot Number | 2420680403 |
| Device Expiration Date | 2019-10-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| 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 | 2018-05-16 |