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 2019-05-24 for VITEK? 2 GN ID TEST KIT 21341 manufactured by Biomerieux, Inc..
[146052763]
A customer in (b)(6) notified biom? Rieux of an injury requiring surgery, and claiming that repetitive opening of vitek? 2 gn id test kits (reference 21341) may have contributed to the injury. The customer complained about pain in the thumbs and forearms when opening the vitek 2 card pouches. The customer reports a strong correlation between the new card pouches, and the development of a ganglion in her right hand. The customer reported that the vitek 2 card pouches changed approximately two years ago, and that the new pouches are difficult to open, and cause pain when opened frequently. The customer reported opening approximately fifty (50) vitek 2 card pouches per day. The customer has reported that, six (6) months after the new card pouches were introduced to the customer (the patient), she developed a ganglion in the right hand. The customer reported that the ganglion grew larger and more painful because of the workload - the ganglion was surgically removed in (b)(6) 2019. The customer (patient) reports that she has been working in the same lab for six (6) years, and never had these issues before; after the previous foil pouches of the vitek 2 cards changed, she developed a ganglion which had to be removed surgically. Although this is not evidence that the card pouches are responsible for the customer injury, the customer made the claim that it is a strong possibility. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2019-00153 |
| MDR Report Key | 8639955 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-24 |
| Date of Report | 2019-07-18 |
| Date Mfgr Received | 2019-06-20 |
| Date Added to Maude | 2019-05-24 |
| 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 | 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 GN ID TEST KIT |
| Generic Name | VITEK? 2 GN ID TEST KIT |
| Product Code | LQM |
| Date Received | 2019-05-24 |
| Catalog Number | 21341 |
| 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 | 1. Other | 2019-05-24 |