FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® INSTANT TEST STRIPS
MDR report key: 18110286
·
Received November 10, 2023
Report
- Report Number
- 3011393376-2023-02533
- Event Type
- Malfunction
- Date Received
- November 10, 2023
- Date of Event
- September 7, 2023
- Report Date
- January 16, 2024
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- EG
- 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. THIS CASE, WITH PATIENT IDENTIFIER (B)(6), (SYSTEM 2), IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6), (SYSTEM 1).
Description of Event or Problem · 0
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: "LO" MG/DL (LESS THAN 10 MG/DL; SYSTEM 1) AND 190 MG/DL (SYSTEM 2).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 102886 | ACCU-CHEK ® INSTANT TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | CGA | ROCHE DIABETES CARE, INC. | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Male | NOVORAPID INSULIN| TOUJEO INSULIN |