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 2017-03-01 for VITEK? 2 GRAM-NEGATIVE IDENTIFICATION TEST KIT 21341 manufactured by Biomerieux, Inc.
[68974755]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[68974756]
A customer in (b)64) contacted biom? Rieux to report a misidentification of a proteus vulgaris external control strain as proteus penneri in association with the vitek? 2 gram-negative (gn) identification (id) test kit. Repeat test obtained proteus hauseri. There is no indication or report from the laboratory that the discrepant result led to any adverse event related to any patient's state of health. There was no patient directly associated with the external control strain. Culture submittal has been requested by biom? Rieux for internal investigation. Biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[74808497]
A customer in (b)(6) contacted biom? Rieux to report a misidentification of a proteus vulgaris external control strain as proteus penneri in association with the vitek? 2 gram-negative (gn) identification (id) test kit. Repeat test obtained proteus hauseri. An internal biom? Rieux investigation was performed. The submitted isolate was subcultured and vitek? 2 gn card testing included individual organism suspensions on each of the two (2) customer implicated lots (241394340 and 241396640) as well as a random lot, in duplicate. Also performed was api? 20 e test strip testing. All six (6) vitek? 2 gn cards tested resulted in the same low discrimination identification of proteus penneri/proteus hauseri. The api? 20 test strip resulted in an excellent identification (b)(4) of proteus vulgaris group. Note, the isolate demonstrated swarming on tsab agar, compatible with an identification of proteus vulgaris. A review of the customer's proteus penneri/proteus hauseri data against expected reactions for proteus vulgaris demonstrated five (5) atypical negative reactions (off, bglu, proa, 0129r and ggaa), according to the gn knowledge base, contributing to the misidentification. Review of the internal proteus penneri/proteus hauseri data demonstrated three (3) of the same atypical negative reactions (bglu, proa and ggaa). An increased number of atypical negative results can indicate a strain with decreased viability or an atypical strain.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00078 |
| MDR Report Key | 6368612 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-03-01 |
| Date of Report | 2017-04-25 |
| Date Mfgr Received | 2017-03-28 |
| Device Manufacturer Date | 2016-09-30 |
| Date Added to Maude | 2017-03-01 |
| 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 |
| 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 | 2017-03-01 |
| Catalog Number | 21341 |
| Lot Number | 241394340 |
| Device Expiration Date | 2017-09-30 |
| 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 | 2017-03-01 |