FDA Adverse Event
Injury
Summary report: N
ARC INSTATEMP
MDR report key: 6664576
·
Received June 23, 2017
Report
- Report Number
- 3011197139-2017-00100
- Event Type
- Injury
- Date Received
- June 23, 2017
- Date of Event
- May 24, 2017
- Report Date
- June 14, 2017
- Manufacturer
- ARC DEVICES USA INC.
- Product Code
- FLL
- UDI-DI
- 05391525570006
- PMA / PMN Number
- K152905
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
Narratives
Description of Event or Problem · 1
THE CONSUMER/MOTHER REPORTED THEIR THERMOMETER WAS GIVING FALSE NEGATIVE READINGS. THE DEVICE ALLEGEDLY WAS READING 5-6 DEGREES LOWER THAN THE CHILD'S ACTUAL TEMPERATURE. THE CHILD WAS TREATED AT AN EMERGENCY ROOM WHERE A FEVER WAS CONFIRMED. THE CONSUMER ALSO STATED THAT THE CHILD HAD A FEBRILE SEIZURE. ARC DEVICES HAS REQUESTED THAT THE PRODUCT BE RETURNED TO OUR COMPANY FOR LAB ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 444852 | ARC INSTATEMP | INFRARED THERMOMETER | FLL | ARC DEVICES USA INC. | CF1-0196 | 05391525570006 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 MO | Other |