FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA TEST STRIPS
MDR report key: 2991277
·
Received March 6, 2013
Report
- Report Number
- 1823260-2013-01336
- Event Type
- Malfunction
- Date Received
- March 6, 2013
- Date of Event
- February 7, 2013
- Report Date
- July 29, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6). THIS MEDWATCH IS FOR THE AVIVA NANO SYSTEM. REFERENCE MEDWATCH WITH (B)(6) FOR THE AVIVA EXPERT SYSTEM. DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
REPORTER STATED THAT PATIENT RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT METERS, WITHIN 3 MINUTES: 9.0 MMOL/L AND 13.0 MMOL/L (AVIVA EXPERT) AND 3.4 MMOL/L (AVIVA NANO) THE CUSTOMER WAS HAVING HYPOGLYCEMIC SYMPTOMS OF "ILL" AND "VERY UNWELL" AT THE TIME OF THESE RESULTS. THE CUSTOMER'S FATHER TREATED HIM WITH AN UNSPECIFIED NUMBER OF GLYCOTABS. THE CUSTOMER RECOVERED AND IS CURRENTLY FEELING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96327 | ACCU-CHEK ® AVIVA TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Male | UNSPECIFIED INSULIN| UNSPECIFIED INSULIN |