MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-04-23 for VITEK 2 GRAM-POSITIVE SUSCEPTIBILITY TEST KIT 22226 manufactured by Biomerieux, Inc..
[4461231]
On (b)(6) 2014, (b)(6) reported a (b)(6) using a vitek 2 gram-positive susceptibility (ast-gp67) test kit. A septic patient was tested (b)(6); gentamycin and oxacillin therapy was prescribed by the physician. The following day, blood culture was reported by a vitek 2 ast-gp67 test card as (b)(6), and the patient's treatment was changed to vancomycin. The laboratory technologist, upon noticing this change, repeated the test with a vitek 2 ast-gp67 test card and alternate method which produced (b)(6). After approximately two days of vancomycin treatment, the physician returned to the original treatment regimen of gentamycin and oxacillin. The customer indicated that although the patient treatment was changed to an antibiotic which was not optimal for a brief period, there was no adverse impact to the patient. This event is reportable as a adverse event, as the incorrect (b)(6) result influenced the physician's decision to revise therapy resulting in non-optimal treatment. Upon retesting the isolate, the ast result was (b)(6). Additional manual testing also confirmed the initial treatment prescribed by the physician was more appropriate. There is no indication or report from the hospital or treating physician to biomerieux that the (b)(6) result led to an adverse event related to the patient state of health. This event is being reported since treatment intervention was impacted in association with the (b)(6) result. The patient isolate is no longer available for testing; however, a biomerieux investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2014-00002 |
| MDR Report Key | 3866784 |
| Report Source | 05,06,07 |
| Date Received | 2014-04-23 |
| Date of Report | 2014-04-23 |
| Date of Event | 2014-04-01 |
| Date Mfgr Received | 2014-04-01 |
| Device Manufacturer Date | 2014-01-03 |
| Date Added to Maude | 2014-07-01 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | RYAN LEMELLE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318582 |
| Manufacturer G1 | BIOMERIEUX, INC. |
| Manufacturer Street | 595 ANGLUM RD. |
| Manufacturer City | HAZELWOOD 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-POSITIVE SUSCEPTIBILITY TEST KIT |
| Generic Name | VITEK 2 AST-GP67 TEST KIT |
| Product Code | LTW |
| Date Received | 2014-04-23 |
| Catalog Number | 22226 |
| Lot Number | 132312540 |
| Device Expiration Date | 2015-07-05 |
| 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 | HAZELWOOD MO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-04-23 |