FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® INSIGHT METER
MDR report key: 5237295
·
Received November 19, 2015
Report
- Report Number
- 3011393376-2015-05160
- Event Type
- Malfunction
- Date Received
- November 19, 2015
- Date of Event
- November 2, 2015
- Report Date
- August 5, 2025
- Manufacturer
- SANMINA CORPORATION
- Product Code
- NBW
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.
Description of Event or Problem · 1
THERE IS A BLACK LINE ON THE DEVICE DISPLAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 767723 | ACCU-CHEK ® INSIGHT METER | BLOOD GLUCOSE MONITORING DEVICE | NBW | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Male |