FDA Adverse Event
Injury
Summary report: N
DARIO BLOOD GLUCOSE MONITORING SYSTEM
MDR report key: 8193106
·
Received December 23, 2018
Report
- Report Number
- 3010606081-2018-00021
- Event Type
- Injury
- Date Received
- December 23, 2018
- Date of Event
- November 28, 2018
- Report Date
- December 23, 2018
- Manufacturer
- LABSTYLE INNOVATIONS LTD.
- Product Code
- NBW
- PMA / PMN Number
- K150817
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON (B)(6) 2018, THE CUSTOMER CONTACT DARIO TO REPORT BLOOD GLUCOSE READINGS ARE HIGHER THAN THEY SHOULD BE - ABOUT 50/60 POINTS HIGHER THAN HIS OTHER METER HE USES. THE CUSTOMER WENT TO SEE HIS DOCTOR (CLINIC LOCATED IN AN HOSPITAL) FOR A CHECK DUE TO THE BLOOD GLUCOSE READINGS BEING HIGHER COMPARE TO HIS OTHER METER. WHEN CUSTOMER TESTED DARIO METER WITH CONTROL SOLUTION TO VERIFY ACCURACY OF METER AND STRIPS, THE METER READ WITHIN RANGE. STRIPS AND METER LABELING WERE REVIEWED - NO NON-CONFORMANCE NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1032340 | DARIO BLOOD GLUCOSE MONITORING SYSTEM | NBW | NBW | LABSTYLE INNOVATIONS LTD. | 1021-02 | 1804171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |