MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-18 for AFINION 2 1116682 manufactured by Abbott Diagnostics Technologies As.
[188868666]
The customer reported that she was opening the instrument to run a crp test and experienced electrostatic discharge from the afinion adapter/power cable. The instrument short circuited and was turned off. The customer tried another cable and the instrument worked again which indicates that the cable caused the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003045237-2020-00004 |
| MDR Report Key | 9850042 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-16 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-18 |
| 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 MONICA VALLESTAD |
| Manufacturer Street | KJELS?SVEIEN 161 P.O.BOX 6863 RODEL?KKA |
| Manufacturer City | OSLO, 0504 |
| Manufacturer Country | NO |
| Manufacturer Postal | 0504 |
| Manufacturer G1 | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
| Manufacturer Street | KJELS P.O.BOX 6863 RODEL |
| Manufacturer City | OSLO, 0504 |
| Manufacturer Country | NO |
| Manufacturer Postal Code | 0504 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFINION 2 |
| Generic Name | ANALYZER |
| Product Code | JQT |
| Date Received | 2020-03-18 |
| Model Number | 1116682 |
| Catalog Number | 1116682 |
| Lot Number | AF20006180 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIAGNOSTICS TECHNOLOGIES AS |
| Manufacturer Address | KJELS?SVEIEN 161 P.O.BOX 6863 RODEL?KKA OSLO, 0504 SW 0504 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-18 |