MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-07 for ALERE AFINION AS100 1115175 manufactured by Alere Technologies As.
[107753626]
Customer reports he experienced a mild electric shock by the analyzer. The customer placed his finger on the left side of the analyzer touchscreen and received a shock. As soon as he experienced the shock, the analyzer screen slowly faded away and will no longer turn on. No harm occured to the end user due to the shock.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003045237-2018-00005 |
| MDR Report Key | 7489650 |
| Date Received | 2018-05-07 |
| Date of Report | 2018-05-07 |
| Date of Event | 2018-04-24 |
| Date Mfgr Received | 2018-04-24 |
| Date Added to Maude | 2018-05-07 |
| 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 | KJELSAASVEIEN 161 |
| Manufacturer City | OSLO, 0884 |
| Manufacturer Country | NO |
| Manufacturer Postal | 0884 |
| Manufacturer G1 | ALERE TECHNOLOGIES AS |
| Manufacturer Street | KJELSAASVEIEN 161 |
| Manufacturer City | OSLO, 0884 |
| Manufacturer Country | NO |
| Manufacturer Postal Code | 0884 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ALERE AFINION AS100 |
| Generic Name | ANALYZER |
| Product Code | JQT |
| Date Received | 2018-05-07 |
| Model Number | 1115175 |
| Catalog Number | 1115175 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE TECHNOLOGIES AS |
| Manufacturer Address | KJELSAASVEIEN 161 OSLO, 0884 NO 0884 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-05-07 |