FDA Adverse Event
Injury
Summary report: N
DARIO BLOOD GLUCOSE MONITORING SYSTEM
MDR report key: 8338414
·
Received February 14, 2019
Report
- Report Number
- 3010606081-2019-00003
- Event Type
- Injury
- Date Received
- February 14, 2019
- Date of Event
- January 15, 2019
- Report Date
- February 14, 2019
- Manufacturer
- LABSTYLE INNOVATIONS LTD.
- Product Code
- NBW
- PMA / PMN Number
- K150817
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON (B)(6) 2019, THE USER CONTACTED DARIO TO REPORT HIGH BLOOD GLUCOSE READINGS. DURING THE CONVERSATION, SHE MENTIONED SHE WAS ADMITTED TO THE HOSPITAL TWICE IN THE PAST (THE USER DID NOT GIVE DETAILS REGARDING THE REASONS FOR HER HOSPITALIZATIONS). SHE STATED THAT IN BOTH TIMES THERE WAS A VARIATION OF 100 POINTS IN BLOOD GLUCOSE BETWEEN THE LAB TESTS RESULTS AND DARIO METER READINGS. AT THE TIME OF THE CASE REPORT, THE USER WAS NOT INTERESTED IN TROUBLESHOOTING OR CHECKING HER DARIO DEVICE. SINCE THEN MULTIPLE ATTEMPTS TO FOLLOW UP WITH THE USER WERE MADE, HOWEVER, NO RESPONSE HAS BEEN RECEIVED TO DATE. NO RESOLUTION IS AVAILABLE. ACCORDING TO DARIO SYSTEM LOGS, THE USER KEPT USING HER DARIO METER TO DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 133161 | DARIO BLOOD GLUCOSE MONITORING SYSTEM | NBW | NBW | LABSTYLE INNOVATIONS LTD. | 1021-02 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |