FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® GUIDE TEST STRIPS
MDR report key: 12631085
·
Received October 14, 2021
Report
- Report Number
- 3011393376-2021-03177
- Event Type
- Malfunction
- Date Received
- October 14, 2021
- Date of Event
- September 30, 2021
- Report Date
- December 13, 2021
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- NBW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
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. CASE WITH PATIENT IDENTIFIER (B)(6) IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: LO MG/DL (LOT 102438) AND 148 MG/DL (UNKNOWN LOT).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1534198 | ACCU-CHEK ® GUIDE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | NBW | ROCHE DIABETES CARE, INC. | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Male |