FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® GUIDE TEST STRIPS
MDR report key: 18837026
·
Received March 5, 2024
Report
- Report Number
- 3011393376-2024-00554
- Event Type
- Malfunction
- Date Received
- March 5, 2024
- Date of Event
- March 4, 2024
- Report Date
- April 10, 2024
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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: 125 MG/DL, 265 MNG/DL, 175 MG/DL AND 135 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 165651 | ACCU-CHEK ® GUIDE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | NBW | ROCHE DIABETES CARE, INC. | 104021 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Female |