MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-01-17 for MAGNA PURE96 INSTRUMENT 06541089001 manufactured by Roche Molecular Systems, Inc..
[176096221]
At the time of the incident, the laboratory operator was not wearing eye protection. Within the magna pure 96 system safety manual, it indicates working without personal protective equipment constitutes a risk to life or health. Wear appropriate personal protective equipment, including, but not limited to, the following items: eye protection with side shields. (b)(4). Na.
Patient Sequence No: 1, Text Type: N, H10
[176096222]
A laboratory operator, at a customer site in the netherlands, was splashed in the face with liquid waste from the magna pure 96 instrument. After the incident, the operator went to the emergency room where their eye was rinsed for 30 minutes and evaluated by an ophthalmologist. On the next day, the operator went to an ophthalmologist for a second check. A topical cream and eye drops were administrated for 1 week; no further treatment details were provided. There is no report of any permanent damage / impairment of the eye. At the time of the incident, the operator was not wearing eye protective glasses or goggles. The magna pure 96 instrument is designed to perform automated purification of nucleic acids for in vitro diagnostic purposes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2020-00001 |
| MDR Report Key | 9604680 |
| Report Source | FOREIGN |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-17 |
| Date of Event | 2019-12-23 |
| Date Mfgr Received | 2019-12-23 |
| Date Added to Maude | 2020-01-17 |
| 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 | NA STACIE-ANN CREIGHTON |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537112 |
| Manufacturer G1 | ROCHE INTERNATIONAL ROTKREUZ |
| Manufacturer Street | FORRENSTRASSE 2 NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAGNA PURE96 INSTRUMENT |
| Generic Name | CLINICAL SAMPLE CONCENTRATOR |
| Product Code | JJH |
| Date Received | 2020-01-17 |
| Model Number | NA |
| Catalog Number | 06541089001 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-01-17 |