FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® GUIDE TEST STRIPS
MDR report key: 13946542
·
Received March 30, 2022
Report
- Report Number
- 3011393376-2022-00979
- Event Type
- Malfunction
- Date Received
- March 30, 2022
- Date of Event
- March 15, 2022
- Report Date
- March 30, 2022
- Manufacturer
- ROCHE DIABETES CARE, INC.
- Product Code
- NBW
- PMA / PMN Number
- K160944
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS CASE, WITH PATIENT IDENTIFIER (B)(6), IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6). PRODUCT IS NO LONGER AVAILABLE TO BE RETURNED.
Description of Event or Problem · 0
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 583 MG/DL (UNKNOWN LOT #) AND 154 MG/DL (LOT 102982). THE READINGS WERE OBTAINED USING TWO DIFFERENT VIALS OF TEST STRIPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2731265 | ACCU-CHEK ® GUIDE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | NBW | ROCHE DIABETES CARE, INC. | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male |