MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-12-13 for BIOPLEX 2200 660-0000 manufactured by Bio-rad Laboratories, Inc.
[94734367]
Laboratory manager called on (b)(6), 2017 to inform that a technician was injured (cut) while removing a stuck sample tray. They are concerned because they were running (b)(6) samples during the incident. Bio-rad technical support representative contacted the injured technician and gathered some information regarding the incident. The technician informed that the incident happened on (b)(6) 2017. He was running (b)(6) samples when he received an error. He can't remember what the error was but he noticed the sample tray was stuck. He removed the front cover of the bioplex and tried to get the rack out with some force and that is when he cut his hand. He was wearing lab coat, gloves and eye shield. He immediately rinsed his hand with soap water, wiped with alcohol swab and applied bandage. He went to seek treatment the next day on (b)(6) 2017. He was tested for (b)(6) and the result was negative. He was also given prophylaxis treatment of isentress 400mg twice daily and truvada 200mg daily for 30 days. He was retested for (b)(6) in october and the result was negative. Customer was advised not to remove stuck trays with force. He was directed to the user manual and was given instruction to safely remove the tray using the maintenance user interface.
Patient Sequence No: 1, Text Type: N, H10
[94734368]
Received a call on (b)(6) 2017. Technician reported that while he was running a sample on september (b)(6) 2017, he received an error message. The sample rack was stuck. He removed the front cover to try to get the rack out with some force and that is when he cut his hand. He was running hiv test on the system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000135116-2017-00001 |
| MDR Report Key | 7113356 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-12-13 |
| Date of Report | 2017-12-12 |
| Date of Event | 2017-09-12 |
| Date Mfgr Received | 2017-11-27 |
| Device Manufacturer Date | 2015-05-06 |
| Date Added to Maude | 2017-12-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS PATRICIA KLIMLEY |
| Manufacturer Street | 5500 E SECOND ST |
| Manufacturer City | BENICIA CA 94510 |
| Manufacturer Country | US |
| Manufacturer Postal | 94510 |
| Manufacturer Phone | 5107416263 |
| Manufacturer G1 | BIO-RAD LABORATORIES, INC |
| Manufacturer Street | 4000 ALFRED NOBEL DR |
| Manufacturer City | HERCULES CA 94547 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94547 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOPLEX 2200 |
| Generic Name | BIOPLEX 2200 SYSTEM |
| Product Code | NSU |
| Date Received | 2017-12-13 |
| Model Number | BIOPLEX 2200 |
| Catalog Number | 660-0000 |
| Lot Number | N/A |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIO-RAD LABORATORIES, INC |
| Manufacturer Address | 4000 ALFRED NOBEL DR. HERCULES CA 94547 US 94547 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-12-13 |