FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® GUIDE TEST STRIPS
MDR report key: 17817692
·
Received September 26, 2023
Report
- Report Number
- 3011393376-2023-02175
- Event Type
- Malfunction
- Date Received
- September 26, 2023
- Date of Event
- September 19, 2023
- Report Date
- October 12, 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
- PA, 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: 21 MG/DL AT 8:20 AM ON (B)(6) 2023. 71 MG/DL AT 8:25 AM ON (B)(6) 2023. 256 MG/DL AT 8:42 AM ON (B)(6) 2023. 253 MG/DL AT 8:44 AM ON (B)(6) 2023. 98 MG/DL AT 8:55 AM ON (B)(6) 2023.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 972640 | ACCU-CHEK ® GUIDE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | NBW | ROCHE DIABETES CARE, INC. | 104216 | 00365702719101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male |