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..
[146053123]
A customer in (b)(6) notified biom? Rieux of injuries for three employees, in association with the use of the vitek? 2 gn id test kit (reference 21341). The lot numbers for the vitek 2 cards associated with this report were not provided. The customer has reported that employees complain of pain from opening the vitek 2 card pouches and have incurred sick leaves due to the frequent opening of the vitek 2 card pouches (no matter the card type). The customer stated that approximately 240 vitek 2 card pouches are opened per day; some days up to 300 cards are opened and used. The customer indicated that considerably more strength is necessary than with the previous foil card pouches. In addition the notches are often not big enough, so even more strength is needed to open the card pouches. The customer also stated the tear of the pouch is often not parallel to the edge. Therefore, only one corner of the pouch is open and this often happens on the other corner as well. Consequently two corners are gone, but one still cannot take the card from the pouch. The customer claims that, as a consequence, three (3) coworkers have been impacted. The employee associated with this medwatch report reportedly had serious irritations of the tendon sheath, had to wear a splint, and be shifted to workstations with less hand stress. A biom? Rieux internal investigation has been initiated. Note: the detail of the other two laboratory personnel are documented in medwatch reports 1950204-2019-00154 and 1950204-2019-00156.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1950204-2019-00155 |
| MDR Report Key | 8639956 |
| 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 |