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 2016-08-04 for VITEK? 2 GRAM NEGATIVE ID TEST KIT 21341 manufactured by Biomerieux, Inc.
[51199680]
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Patient Sequence No: 1, Text Type: N, H10
[51199681]
A customer notified biomerieux of a mis-identification when using the vitek 2 gram (b)(6) id test kit. A pseudomaonas aeruginosa sample was identified by the test kit as a burkholderia. When specifically asked the customer noted no injury or death happened as a result of the mis-identifications. An investigation has been initiated by biomerieux to investigate this event.
Patient Sequence No: 1, Text Type: D, B5
[57600119]
This report was initially submitted following notification that a customer in canada reported a mis-identification of pseudomonas aeruginosa as burkholderia cepacia group when tested in the vitek? 2 gn id card lot # 241354540. The customer confirmed the identification using maldi-tof. The customer did not comply with biom? Rieux request for raw data or strain submittal. The customer also reported testing the pseudomonas isolates from plates incubated at 42c which is outside of the recommended range for the gn card (35-37c). Two lab reports were submitted with each giving the same bionumber. According to the vitek? 2 gn knowledge base, both lab reports showed nine (9) atypical reactions (atypical positive: ado, larl, dcel & dtag; atypical negative: lhisa, cmt, o129r, lmlta, llata). Testing from plates incubated outside of the recommended range may cause atypical reactions as compared to the gn knowledge base. These atypical reactions may cause the isolate to be unidentified or mis-identified. Evaluation of manufacturing batch records indicated the lot met final qc release criteria. There were no issues observed on initial qc performance testing. Based on the investigation, there is no evidence to suggest the vitek? 2 gn id card lot 241354540 is performing outside of specifications.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2016-00082 |
| MDR Report Key | 5846486 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-08-04 |
| Date of Report | 2016-06-09 |
| Date Mfgr Received | 2016-06-09 |
| Date Added to Maude | 2016-08-04 |
| 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 | 2016-08-04 |
| Catalog Number | 21341 |
| Lot Number | 241354540 |
| Device Expiration Date | 2016-08-28 |
| 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 | 2016-08-04 |