MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-13 for VITEK? 2 AST-N233 TEST KIT 413117 manufactured by Biomerieux, Inc.
[72953334]
A customer from (b)(6) notified biom? Rieux of some strains that initial results were resistant (r) for imipene, ertapeneme, e coli, morganella, and proteus associated with vitek? 2 ast-n233 test kit. Guidance from biom? Rieux to inspect product packaging, revealed puncture holes in the card foil pack. There is no indication or report from the laboratory or physician that the discrepant result led to any adverse event related to a patient's state of health. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
[75952276]
An internal biom? Rieux investigation was performed with results as follows: this investigation was initiated in response to a customer complaints reporting holes in the white card pouches of some cards at the stitch seam. The root cause of the defect was linked to the design of the wheel that applies the stitch seal to the pouch. On (b)(6) 2017, stitch wheels with a new design were installed that resolve the issue. Fsca 3445 will be issued, including a customer notification with instructions for inspecting pouches prior to use in order to detect breaches and reduce the likelihood of using cards exposed to moisture. The customer letter will also explain the potential effects of moisture exposure on card performance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1950204-2017-00119 |
| MDR Report Key | 6489474 |
| Date Received | 2017-04-13 |
| Date of Report | 2017-05-17 |
| Date Mfgr Received | 2017-04-20 |
| Device Manufacturer Date | 2016-12-15 |
| Date Added to Maude | 2017-04-13 |
| 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 | MS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | FSCA 3445 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VITEK? 2 AST-N233 TEST KIT |
| Generic Name | VITEK? 2 AST-N233 TEST KIT |
| Product Code | JWY |
| Date Received | 2017-04-13 |
| Catalog Number | 413117 |
| Lot Number | 6330202103 |
| Device Expiration Date | 2018-06-16 |
| 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 SAINT LOUIS MO 63042 US 63042 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-13 |