MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-20 for ALERE AFINION AS100 AS0036881 1115175 manufactured by Abbott Diagnostics Technologies As (prev. Alere).
[140534905]
The user felt an electric shock up her arm. No adverse outcome. The user did not seek medical attention. Serious deterioration in health did not occur.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003045237-2019-00001 |
| MDR Report Key | 8353019 |
| Date Received | 2019-02-20 |
| Date of Report | 2019-02-20 |
| Date of Event | 2019-01-21 |
| Date Mfgr Received | 2019-01-22 |
| Date Added to Maude | 2019-02-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS MONICA VALLESTAD |
| Manufacturer Street | KJELS |
| Manufacturer City | OSLO, 0884 |
| Manufacturer Country | NO |
| Manufacturer Postal | 0884 |
| Manufacturer G1 | ABBOTT DIAGNOSTICSTECHNOLOGIES AS (PREV ALERE) |
| Manufacturer Street | KJELS |
| Manufacturer City | OSLO, 0884 |
| Manufacturer Country | NO |
| Manufacturer Postal Code | 0884 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALERE AFINION AS100 |
| Generic Name | ANALYZER |
| Product Code | JQT |
| Date Received | 2019-02-20 |
| Model Number | AS0036881 |
| Catalog Number | 1115175 |
| Lot Number | 10175646 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT DIAGNOSTICS TECHNOLOGIES AS (PREV. ALERE) |
| Manufacturer Address | KJELS?SVEIEN 161 OSLO, 0884 NO 0884 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-02-20 |