FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® GUIDE TEST STRIPS
MDR report key: 13099236
·
Received December 28, 2021
Report
- Report Number
- 3011393376-2021-04019
- Event Type
- Malfunction
- Date Received
- December 28, 2021
- Date of Event
- December 16, 2021
- Report Date
- January 28, 2022
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- NBW
- UDI-DI
- 00365702710108
- PMA / PMN Number
- K160944
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THIS CASE, WITH PATIENT IDENTIFIER (B)(6) (SYSTEM 1), IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6) (SYSTEM 2).
Description of Event or Problem · 0
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 256 MG/DL USING TEST STRIPS WITH LOT # 102725 AND 116 MG/DL USING TEST STRIPS WITH LOT # 102680.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1999737 | ACCU-CHEK ® GUIDE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | NBW | ROCHE DIABETES CARE, INC. | 07453710001 | 102725 | 00365702710108 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female |