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 2018-06-26 for VITEK? 2 GP TEST KIT 21342 manufactured by Biomerieux, Inc..
[112848290]
A customer in (b)(6) reported a misidentification when testing two blood cultures from one patient, in association with the vitek? 2 gp test kit (lot 2420650203). On (b)(6) 2018, the first culture was twice identified as enterococcus faecium (98%). And the second culture result was low discrimination staphylococcus hominis. The strain was cocci gram positive and catalase positive. The customer performed testing from (b)(6) cna agar + 5% sheep blood, and chromid? Cps agar. The customer believed the colony from the first culture looked like a staphylococcus, so the strain was sent to the reference laboratory for testing with vitek ms, and was identified as staphylococcus hominis. The customer stated a result of staphylococcus hominis was reported to the physician without delay, there is no indication or report from the customer that the misidentification impacted the patient's state of health. A biom? Rieux internal investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2018-00238 |
| MDR Report Key | 7639094 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-06-26 |
| Date of Report | 2018-10-29 |
| Date of Event | 2018-03-29 |
| Date Mfgr Received | 2018-10-04 |
| Device Manufacturer Date | 2018-03-08 |
| Date Added to Maude | 2018-06-26 |
| 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 | MR. JEFF SCANLAN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147318694 |
| Manufacturer G1 | BIOMERIEUX, INC. |
| Manufacturer Street | 595 ANGLUM ROAD |
| 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 GP TEST KIT |
| Generic Name | VITEK? 2 GP TEST KIT |
| Product Code | LQL |
| Date Received | 2018-06-26 |
| Catalog Number | 21342 |
| Lot Number | 2420650203 |
| Device Expiration Date | 2019-09-07 |
| 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 HAZELWOOD MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-26 |