MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-01-30 for KIT ELECSYS CLEAN-CELL M 2X2 L 04880293190 manufactured by Roche Diagnostics.
[3230463]
The customer experienced the clean cell solution splashing into her eye while putting the solution onto the cobas e601 analyzer serial number (b)(4). The customer was not wearing any personal protective equipment at the time of the event. The customer stated the bottle was really full and heavy and when she picked it up to put it in position on the analyzer, the bottle slipped causing her to squeeze the bottle and splash the clean cell into her eye. She did not note any defect with the bottle. The customer visited the er where her eye was flushed with water for 15 minutes. She also received a tetanus shot and antibiotics for the injury. The customer's eye was red and inflamed. Her diagnosis was "chemical conjunctivitis/chemical burn to left eye. " the customer was dismissed from work for five days by the physician and was to follow up with an ophthalmologist. The ophthalmologist put artificial tears in her eye and stated there was no permanent damage to her eye. She returned to work (b)(6) 2013 and stated she was not having any problems due to the event.
Patient Sequence No: 1, Text Type: D, B5
[10490985]
It was unknown if the initial reporter sent report to the fda.
Patient Sequence No: 1, Text Type: N, H10
[16996954]
The investigation determined the event was due to a customer handling issue. Product labeling provides instructions to the customer to wear personal protective equipment when handling the product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-00522 |
| MDR Report Key | 2934096 |
| Report Source | 05,06 |
| Date Received | 2013-01-30 |
| Date of Report | 2013-02-15 |
| Date of Event | 2013-01-14 |
| Date Mfgr Received | 2013-01-14 |
| Date Added to Maude | 2013-01-30 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 NA |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG) 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KIT ELECSYS CLEAN-CELL M 2X2 L |
| Generic Name | DETERGENT |
| Product Code | JCB |
| Date Received | 2013-01-30 |
| Model Number | NA |
| Catalog Number | 04880293190 |
| Lot Number | 10207711 |
| ID Number | NA |
| Device Expiration Date | 2014-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-01-30 |