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 2017-04-05 for VITEK? 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT 21341 manufactured by Biomerieux, Inc.
[72102857]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[72102858]
A customer in (b)(6) contacted biom? Rieux to report a misidentification of enterobacter species as klebsiella oxytoca in association with the vitek? 2 gram-negative (gn) identification (id) test kit. The customer tested three times from the same blood specimen on three different days ((b)(6) 2017) and received the same identification to klebsiella oxytoca. Following the third result of klebsiella oxytoca, the customer determined to test the isolate via malditof and via separate vitek? 2 compact. Malditof identified the isolate as enterobacter kobei. Vitek? 2 compact identified the isolate as enterobacter cloacae complex. During troubleshooting it was determined the customer does not perform routine densichek? Maintenance, as indicated in the instructions for use (ifu). In addition, all card cassettes are configured simultaneously before introducing them to the instrument; the associated ifu indicate the cards must be placed into the instrument for processing without delay. The local field service engineer (fse) was dispatched to visit the customer site in order to confirm/perform system maintenance/repair as appropriate. The fse did not identify any system issues that may have led to the discrepant organism identification. Follow-up testing of the patient isolate obtained the expected enterobacter result using both vitek? 2 compact systems. The customer stated the klebsiella oxytoca result was reported to the treating physician. However, the customer indicates that the discrepant result did not lead to any adverse event related to any patient's state of health. Culture submittal has been requested by biom? Rieux for internal investigation. Biom? Rieux investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2017-00111 |
| MDR Report Key | 6460284 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-04-05 |
| Date of Report | 2017-06-29 |
| Date of Event | 2017-02-01 |
| Date Mfgr Received | 2017-06-01 |
| Device Manufacturer Date | 2016-10-23 |
| Date Added to Maude | 2017-04-05 |
| 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 | HAZELWOOD 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 GRAM-NEGATIVE IDENTIFICATION TEST KIT |
| Generic Name | VITEK? 2 GN ID TEST KIT |
| Product Code | JTO |
| Date Received | 2017-04-05 |
| Catalog Number | 21341 |
| Lot Number | 241396640 |
| ID Number | 03573026131913 |
| Device Expiration Date | 2017-10-23 |
| 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 | 2017-04-05 |