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 2017-04-20 for VITEK 2 GN TEST KIT 21341 manufactured by Biomerieux, Inc.
[73389269]
A customer in (b)(6) notified biom? Rieux of a misidentification associated with vitek? Gn test kit (reference 21341) involving an rcpa sample. The customer reported the organism was identified by the vitek? Gn card as spingomonas paucimobilis twice and once as a slashline (brevundimonas vesicularis/diminuta) instead of brevundimonas vesicularis as expected. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[77899854]
A customer from colombia reported discrepant values for the vidas? Prolactin test kit when compared to the chemiluminescence method, for prolactin control samples from a patient that were tested on (b)(6) 2017. The customer did not provide a sample or test report for evaluation. An investigation was performed. A review of quality records confirmed the vidas? Prolactin test kit (lot 1005172980) met specifications. The quality product laboratory has tested a calibration sample and six internal samples on a retained vidas? Prolactin test kit (lot 1005172980). The results were: (b)(6). The results obtained for the calibration sample and six internal samples were within the specifications. The analysis of the control charts plus one additional sample of high concentration ([123. 5-199. 54] ng/ml 3is) showed that vidas? Prolactin test kit (lot 1005172980) was within the trend of the other batches. The vidas? Prolactin test kit (lot 1005172980) performed as intended. The customer did not provide a sample or information related to the other method used, thus further investigation is not possible.
Patient Sequence No: 1, Text Type: N, H10
[77899855]
The previous supplement was incorrectly submitted and is not associated with this device and event.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00126 |
| MDR Report Key | 6509086 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-20 |
| Date of Report | 2017-08-16 |
| Date Mfgr Received | 2017-07-25 |
| Date Added to Maude | 2017-04-20 |
| 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 | 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 GN TEST KIT |
| Generic Name | VITEK 2 GN TEST KIT |
| Product Code | JTO |
| Date Received | 2017-04-20 |
| Catalog Number | 21341 |
| Lot Number | 241393910 |
| Device Expiration Date | 2017-09-26 |
| 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 | 2017-04-20 |