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 2017-01-20 for VITEK? 2 GN ID TEST KIT 21341 manufactured by Biomerieux, Inc.
[65387581]
A customer from the united states reported to biom? Rieux a misidentification of an api (american proficiency institute) survey sample of proteus vulgaris, as proteus penneri in association with the vitek? 2 gn id test kit. The repeated test result was proteus penneri. The customer stated they had a low discrimination and performed an indole test on the organism, which was negative indicating proteus penneri. The test reports were requested from the customer. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[68239955]
Biom? Rieux conducted an internal investigation: the organism was tested on multiple lots of gn cards in duplicate. The api? 20 e was performed, as was the vitek? Ms. On 2 of the customer lots, a low discrimination call of p. Penneri / p. Hauseri was obtained. On the remaining 2 customer lots tested and the random lot, a low discrimination call of p. Penneri / p. Pneumotropica was obtained. Api? 20 e gave a good identification call of p. Vulgaris group. Vitek? Ms gave a low discrimination call of p. Penneri / p. Vulgaris. Since the organism is indole positive, the vitek? Ms call of p. Vulgaris would be correct. A comparison of reaction results for cards giving the misidentification call of p. Penneri / p. Hauseri against the expected reaction results for p. Vulgaris revealed 3 atypical negative reactions (ple, ilatk, aglu). A comparison of reaction results for cards giving the misidentification call of p. Penneri/p. Pneumotropica against the expected reaction results for p. Vulgaris revealed 4 atypical negative reactions (proa, ple, ilatk, aglu). This is an atypical isolate. A complaint history review was completed for this issue during the last 13 month timeframe with no implication of a trend. No further action is warranted at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00019 |
| MDR Report Key | 6266493 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-01-20 |
| Date of Report | 2017-02-15 |
| Date Mfgr Received | 2017-01-19 |
| Device Manufacturer Date | 2016-08-29 |
| Date Added to Maude | 2017-01-20 |
| 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 | 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 ID TEST KIT |
| Generic Name | VITEK? 2 GN ID TEST CARD |
| Product Code | JTO |
| Date Received | 2017-01-20 |
| Catalog Number | 21341 |
| Lot Number | 241391140 |
| Device Expiration Date | 2017-08-27 |
| 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 | 2017-01-20 |