FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® GUIDE TEST STRIPS
MDR report key: 15174866
·
Received August 5, 2022
Report
- Report Number
- 3011393376-2022-02349
- Event Type
- Malfunction
- Date Received
- August 5, 2022
- Date of Event
- July 31, 2022
- Report Date
- August 23, 2022
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- 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: INCIDENT 1 / (B)(6) 2022: 199 MG/DL, 93MG/DL AND 106 MG/DL. INCIDENT 2 / (B)(6) 2022: 85 MG/DL AND 350 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2520793 | ACCU-CHEK ® GUIDE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | NBW | ROCHE DIABETES CARE, INC. | 103157 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female | AMLODIPINO 5MG| LOSARTAN 50| METFORMINA 500MG| METFORMINA 800MG| UNKNOWN INSULIN, 35IU |