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 ALERE AFINION AS100 ANALYZER manufactured by Abbott Diagnositcs Technologies As.
[188868424]
The customer reported that the afinion adapter/power cable exhibited static charge to the staff and no longer functions per conformance connected to afinion as100. When requested the customer confirmed that the static electricity came from the instrument and not from the cord. The incident happened when the user was touching the instrument. There was no injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003045237-2020-00002 |
| MDR Report Key | 9847480 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-20 |
| Date Mfgr Received | 2020-02-25 |
| 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 P.O.BOX 6863 RODEL |
| 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 | ALERE AFINION AS100 ANALYZER |
| Generic Name | ANALYZER |
| Product Code | JQT |
| Date Received | 2020-03-18 |
| 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 | 1. Other | 2020-03-18 |