FDA Adverse Event
Malfunction
Summary report: N
ALERE AFINION AS100 ANALYZER
MDR report key: 11745344
·
Received April 29, 2021
Report
- Report Number
- 3003045237-2021-00003
- Event Type
- Malfunction
- Date Received
- April 29, 2021
- Date of Event
- April 14, 2021
- Report Date
- April 22, 2021
- Manufacturer
- ABBOTT DIAGNOSTICS TECHNOLOGIES AS
- Product Code
- JQT
- PMA / PMN Number
- K180296
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INSTRUMENT WILL BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. THE INCIDENT RELATES TO THE OLD POWERPACK.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT HE TRIED TO UPDATE SOFTWARE OF THE AFINION AS100 INSTRUMENT. THE CUSTOMER IS USING AFINION AS100 WITH SERIAL NUMBER (B)(4). HOWEVER WHILE THE INSTRUMENT WAS UPDATING THE LAB TECHNICIAN MISTAKENLY MOVED THE POWER SUPPLY WHICH CAUSED AN ELECTRIC SPARK AND THE ELECTRIC METER WENT OFF. THE INSTRUMENT WAS RESTARTED THREE TIMES BY REMOVING THE POWER SUPPLY AND STARTING THE INSTRUMENT UP AGAIN, AFTER WHICH INFO CODE 301 THREE TIMES. NO PERSON WAS INVOLVED IN THE ELECTRIC SPARK. THERE WAS NO INJURY. THE MANUFACTURER ASKED THE CUSTOMER NOT TO TURN THE INSTRUMENT BACK ON, THE INSTRUMENT NEEDS TO BE REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 646848 | ALERE AFINION AS100 ANALYZER | ANALYZER | JQT | ABBOTT DIAGNOSTICS TECHNOLOGIES AS | 1115027 | 10158166 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |