FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® INSTANT TEST STRIPS
MDR report key: 18266839
·
Received December 5, 2023
Report
- Report Number
- 3011393376-2023-02717
- Event Type
- Malfunction
- Date Received
- December 5, 2023
- Date of Event
- November 29, 2023
- Report Date
- February 27, 2024
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- CGA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
CORRECTION - THE UNIQUE IDENTIFIER NUMBERS WAS UPDATED IN SECTION D4 BASED ON THE RETURNED PRODUCT.
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: 304 MG/DL (USER'S METER) AND 129 MG/DL (DIFFERENT ROCHE METER). THE SAME LOT OF TEST STRIPS WAS USED WITH EACH METER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2064453 | ACCU-CHEK ® INSTANT TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | CGA | ROCHE DIABETES CARE, INC. | 302526 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Male | UNKNOWN GLUCOSE-LOWERING MEDICATION. |