FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® GUIDE TEST STRIPS
MDR report key: 16224709
·
Received January 23, 2023
Report
- Report Number
- 3011393376-2023-00192
- Event Type
- Malfunction
- Date Received
- January 23, 2023
- Date of Event
- January 11, 2023
- Report Date
- May 10, 2023
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- NBW
- UDI-DI
- 00365702719101
- PMA / PMN Number
- K160944
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 150-225 MG/DL (HCP METER) AND 400-500 MG/DL (GUIDE). THE CUSTOMER COULD NOT RECALL THE EXACT BLOOD GLUCOSE RESULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 431866 | ACCU-CHEK ® GUIDE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | NBW | ROCHE DIABETES CARE, INC. | 08256292001 | 103477 | 00365702719101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male |