MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-01-03 for ALERE AFINION AS100 ANALYZER 1116053 manufactured by Abbott Diagnositcs Technologies As.
[188869021]
A investigation is ongoing for afinion analyzers related to similar incidents and the investigation to date has concluded that electric shock has not been demonstrated with the analyzers. Rather, static discharge may be possible and is more consistent with the description of the incident. Per the health hazard evaluation static discharge does not pose a risk to harm. Although there was no injury reported in this complaint, due to the burnt smell this is considered a potential hazard, which could have th potential to result in burn injury.
Patient Sequence No: 1, Text Type: N, H10
[188869022]
The customer had just removed a test cassette from the analyzer and stretched her hand over the instrument to pick up a glove. Suddenly there was a sound from the instrument and a burnt smell. There was no smoke. The power went off in the whole office. The customer reported that she felt an electric shock in her arm and shoulder and felt a bit numb for a while. When speaking to the customer around 45 minutes after she said she felt fine. No permanent injury was reported. The customer says that she seems to be "an electrical person" since it's not the first time she has experiences similar types of incidents, but not related to afinion instrument. Previous incidents have not been as powerful as this incident. She sometimes experiences similar but small electric shock when touching other equipment. When the customer went back and touched the bench where the instrument was placed she still experienced small electrical shocks.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003045237-2019-00006 |
| MDR Report Key | 9545705 |
| Report Source | USER FACILITY |
| Date Received | 2020-01-03 |
| Date of Report | 2020-01-03 |
| Date of Event | 2019-12-11 |
| Date Mfgr Received | 2019-12-11 |
| Date Added to Maude | 2020-01-03 |
| 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 P.O.BOX 6863 RODEL |
| Manufacturer City | OSLO, 0504 |
| Manufacturer Country | NO |
| Manufacturer Postal | 0504 |
| Manufacturer G1 | ABBOTT DIAGNOSITCS 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 | ALERE AFINION AS100 ANALYZER |
| Generic Name | ANALYZER |
| Product Code | JQT |
| Date Received | 2020-01-03 |
| Model Number | 1116053 |
| Catalog Number | 1116053 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIAGNOSITCS TECHNOLOGIES AS |
| Manufacturer Address | KJELS?SVEIEN 161 P.O.BOX 6863 RODEL?KKA OSLO, 0504 NO 0504 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-03 |