FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® INSTANT TEST STRIPS
MDR report key: 18302817
·
Received December 11, 2023
Report
- Report Number
- 3011393376-2023-02769
- Event Type
- Malfunction
- Date Received
- December 11, 2023
- Date of Event
- December 8, 2023
- Report Date
- March 26, 2024
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES. 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 · 0
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 585 MG/DL (PATIENT'S METER) AND 120 MG/DL (LAB RESULT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2179707 | ACCU-CHEK ® INSTANT TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | CGA | ROCHE DIABETES CARE, INC. | 302397 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |