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 2016-09-30 for VITEK? 2 GRAM NEGATIVE ID TEST KIT 21341 manufactured by Biomerieux, Inc.
[56108311]
A customer notified biomerieux that they had mis-identifications when using the vitek? 2 gram negative id test kit. A patient sample was identified by the test kit as elizabethkingia meningoseptica. Confirmatory testing by a third party laboratory confirmed the organism to be stenotrophomonas maltophilia. When specifically asked, the customer noted no injury or death happened as a result of the mis-identifcations. An investigation will be initiated by biomerieux to investigate this event.
Patient Sequence No: 1, Text Type: D, B5
[67550580]
A customer reported a misidentification of stenotrophomonas maltophilia as elizabethkingia meningoseptica in association with the vitek? 2 gram negative id test kit. The identification was confirmed with bruker ms. The customer stated they repeated the testing with the same result. Subsequently, the customer said they did not repeat the testing. Upon further questioning, the customer said they repeated the testing but did not get an identification of either e. Meningoseptica or s. Maltophilia; however, the customer would not state the result. No lab report was submitted for the repeat testing. A biomerieux investigation was conducted using the information submitted by the customer. No organism or raw data were submitted. A qc lab report was submitted for one of the streamlined qc strains, e. Hormaechei atcc 700323, showing all qc reactions were correct. A patient lab report was submitted showing an excellent identification of elizabethkingia meningoseptica. There were three (3) atypical positive reactions (bgal, dmne, agal) for stenotrophomonas maltophilia according to the gn knowledge base. An increased number of atypical positive reactions can indicate contamination, mixed culture, use of non recommended media or other user set up errors or an atypical strain. However without the strain, or raw data it's not possible to further evaluate the cause of the misidentification. A review of quality control records showed vitek? 2 gn id lot 241367110 met criteria for performance testing and final release.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2016-00138 |
| MDR Report Key | 5991710 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-09-30 |
| Date of Report | 2017-01-30 |
| Date Mfgr Received | 2017-01-03 |
| Date Added to Maude | 2016-09-30 |
| 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 ID TEST KIT |
| Generic Name | VITEK? 2 GRAM NEGATIVE ID TEST KIT |
| Product Code | LRH |
| Date Received | 2016-09-30 |
| Catalog Number | 21341 |
| Lot Number | 241367110 |
| Device Expiration Date | 2017-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2016-09-30 |