FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® GUIDE TEST STRIPS
MDR report key: 13051868
·
Received December 21, 2021
Report
- Report Number
- 3011393376-2021-03950
- Event Type
- Malfunction
- Date Received
- December 21, 2021
- Date of Event
- July 18, 2021
- Report Date
- February 22, 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
- IN, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
THE CUSTOMER REPORTED USING TWO DIFFERENT LOT NUMBERS (101935, EXP. DATE 1/20/2022; 102409, EXP. DATE 8/18/2022), BUT DID NOT KNOW WHICH LOT PRODUCED THE DISCREPANT RESULT.
Additional Manufacturer Narrative · 0
THE CUSTOMER REPORTED USING TWO DIFFERENT LOT NUMBERS (101935, EXP. DATE 1/20/2022; 102409, EXP. DATE 8/18/2022), BUT DID NOT KNOW WHICH LOT PRODUCED THE DISCREPANT RESULT.
Description of Event or Problem · 0
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 401 MG/DL MEASURED WITH ACCU-CHEK GUIDE AND 167 MG/DL MEASURED WITH AN UNKNOWN HOSPITAL METER.
Description of Event or Problem · 0
IT WAS REPORTED THE PATIENT RECEIVED THE FOLLOWING RESULTS WITHIN 15 MINUTES: 401 MG/DL MEASURED WITH ACCU-CHEK GUIDE AND 167 MG/DL MEASURED WITH AN UNKNOWN HOSPITAL METER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1954008 | ACCU-CHEK ® GUIDE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | NBW | ROCHE DIABETES CARE, INC. | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Female | LEVEMIR INSULIN| UNKNOWN ANALOGUE INSULIN |