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 2018-08-09 for VIDAS? RUB IGG II 30221 manufactured by Biomerieux Sa.
[116717566]
A customer from (b)(6) notified biom? Rieux of an operator exposure occurring on (b)(6) 2018 when using the product vidas? Rub igg ii ((b)(4)). Although reference (b)(4) rub igg ii is not registered in the us, a similar device, reference (b)(4) rub igg is approved for the us. When the operator removed the solid phase receptacle (spr) from the spr block at the end of analysis, she was exposed to a drop from the spr in her eye. The sample tested during this run came from a pregnant woman tested for rub igg (positive) and also (b)(6). The operator consulted an ophthalmologist with the material safety data sheet (msds) of the substrate of this test the same day of the incident: no lesion in the eye was observed. A treatment wash with dacudose and vismed was prescribed. The physician considered the risk as low regarding the (b)(6) transmission, because the eye is not a mucosa sensitive to viruses. The operator complained of left eye burning for two days. The msds for this product states that the substrate is an irritant for eyes and can cause serious eye damage. The package insert states as a precautionary statement to wear eye protection. The operator was not wearing eye protection when the incident occurred. Also to be noted, the incident occurred at the end of the test run; therefore, there should have been no patient sample remaining in the spr due to several washing steps. The exposure should have been to the test substrate only. A biom? Rieux internal investigation has been initiated.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3002769706-2018-00138 |
| MDR Report Key | 7767896 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-08-09 |
| Date of Report | 2018-09-19 |
| Date of Event | 2018-07-06 |
| Date Mfgr Received | 2018-08-24 |
| Device Manufacturer Date | 2017-12-22 |
| Date Added to Maude | 2018-08-09 |
| 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 | MRS. CANDACE MARTIN |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | SAINT LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer G1 | BIOMERIEUX SA |
| Manufacturer Street | 376 CHEMIN DE L ORME |
| Manufacturer City | MARCY L ETOILE, RHONE 69280 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 69280 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS? RUB IGG II |
| Generic Name | VIDAS? RUB IGG II |
| Product Code | LFX |
| Date Received | 2018-08-09 |
| Catalog Number | 30221 |
| Lot Number | 1006180020 |
| Device Expiration Date | 2018-12-11 |
| 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 SA |
| Manufacturer Address | 376 CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-09 |