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 2018-03-09 for VITEK? 2 NH ID TEST KIT 21346 manufactured by Biomerieux Inc..
[102318245]
A customer in (b)(6) notified biom? Rieux of discrepant results associated with vitek? 2 nh id test kit (reference 21346) lot 2450221203. The customer was testing an rcpa-qap survey sample (8-2017) identified as aggregatibacter aphrophilus, and vitek 2 identified it as actinobacillus pleuropneumoniae. The customer tested the sample multiple times with the following results: (b)(6). The sample used was for quality assurance testing. There was no effect on any patient treatment or condition. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. Vitek 2 nh id test kit, lot 2450221203 was included in fsca 3445. Per the customer, there was no defect found upon inspection. As stated in fsca 3445, cards with intact integrity can be used. An internal biom? Rieux investigation will be conducted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00095 |
| MDR Report Key | 7327526 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-03-09 |
| Date of Report | 2018-08-21 |
| Date of Event | 2017-12-02 |
| Date Mfgr Received | 2018-07-24 |
| Device Manufacturer Date | 2017-01-03 |
| Date Added to Maude | 2018-03-09 |
| 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 | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| 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 NH ID TEST KIT |
| Generic Name | VITEK? 2 NH ID TEST KIT |
| Product Code | JST |
| Date Received | 2018-03-09 |
| Catalog Number | 21346 |
| Lot Number | 2450221203 |
| Device Expiration Date | 2018-07-05 |
| 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 | 2018-03-09 |