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 2018-03-20 for VITEK? 2 NH TEST KIT 21346 manufactured by Biomerieux Inc..
[103523697]
A customer in the united states reported a misidentification of (b)(6) as neisseria meningitides in association with the vitek? 2 nh test kit. The customer stated the initial identification of n. Meningitides was reported to the physician. The physician requested that the isolate be retested as they believed it to be (b)(6), and the patient was being treated for it. The customer performed repeat testing with the nh card from the original plate, as there was not enough growth for the required mcfarland range. A low discrimination result was received, which did not include (b)(6). The isolate was sent out to a reference lab which reported that the isolate was dead and no identification could be made. The customer stated the isolate is no longer available. There is no indication or report from the hospital or treating physician to biom? Rieux that the discrepant result led to any adverse event related to the patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00111 |
| MDR Report Key | 7355105 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-03-20 |
| Date of Report | 2018-05-24 |
| Date Mfgr Received | 2018-05-01 |
| Device Manufacturer Date | 2017-05-23 |
| Date Added to Maude | 2018-03-20 |
| 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 | MS. ELLEN WELTMER |
| 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 NH TEST KIT |
| Generic Name | VITEK? 2 NH TEST KIT |
| Product Code | JST |
| Date Received | 2018-03-20 |
| Catalog Number | 21346 |
| Lot Number | 2450361203 |
| Device Expiration Date | 2018-11-22 |
| 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 | 2018-03-20 |