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 2018-06-26 for VITEK? 2 GRAM NEGATIVE ID TEST KIT 21341 manufactured by Biomerieux Inc..
[112847064]
A customer from the united states notified biom? Rieux of misidentification results when testing a patient isolate, obtained from a urine sample, with the vitek? 2 gn id test kit (ref 21341), lot 2410505203. The isolate was tested three times with the same lot of vitek 2 gn cards. Each time, vitek 2 provided an identification result of klebsiella oxytoca. The isolate was tested three times with vitek? Ms, and each time an identification of klebsiella pneumonia was obtained. The customer also performed an indole test, which was negative, indicating the strain is klebsiella pneumoniae. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to the patient's state of health. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00237 |
| MDR Report Key | 7638121 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-06-26 |
| Date of Report | 2018-08-29 |
| Date Mfgr Received | 2018-08-04 |
| Device Manufacturer Date | 2018-04-15 |
| Date Added to Maude | 2018-06-26 |
| 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. CANDACE MARTIN |
| 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 | SAINT 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 GRAM NEGATIVE ID TEST KIT |
| Generic Name | VITEK? 2 GN ID TEST KIT |
| Product Code | LQM |
| Date Received | 2018-06-26 |
| Catalog Number | 21341 |
| Lot Number | 2410505203 |
| Device Expiration Date | 2019-04-15 |
| 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 SAINT LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-26 |