FDA Adverse Event
Injury
Summary report: N
DARIO BLOOD GLUCOSE MONITORING SYSTEM
MDR report key: 8059618
·
Received November 12, 2018
Report
- Report Number
- 3010606081-2018-00018
- Event Type
- Injury
- Date Received
- November 12, 2018
- Date of Event
- October 16, 2018
- Report Date
- November 12, 2018
- Manufacturer
- LABSTYLE INNOVATIONS LTD.
- Product Code
- NBW
- PMA / PMN Number
- K150817
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON (B)(6) 2018 THE CUSTOMER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE READINGS (396 AND 353 MG/DL). AS A RESULT, SHE WENT TO THE HOSPITAL. IN THE INTAL INVESTIGATION IT WAS FOUND THAT THE CUSTOMER PLACED THE STRIPS INTO THE DARIO HOUSING WITHOUT THE CARTRIDGE. ASIDE FROM THAT, THE STRIPS WERE EXPIRED AS THEY WERE OPEN FOR OVER A MONTH. PER USER GUIDE, THE STRIPS MUST TO BE KEPT IN THE CARTRIDGE AND THEY SHOULD NOT BE USED AFTER A MONTH OF BEING OPENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 899672 | DARIO BLOOD GLUCOSE MONITORING SYSTEM | SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | NBW | LABSTYLE INNOVATIONS LTD. | 1710111 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |