FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA TEST STRIPS
MDR report key: 3010900
·
Received March 19, 2013
Report
- Report Number
- 1823260-2013-01642
- Event Type
- Malfunction
- Date Received
- March 19, 2013
- Date of Event
- February 20, 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). DEVICE WILL NOT BE RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
CUSTOMER RECEIVED RESULT OF 9.1 MMOL/L ON THE AVIVA NANO SYSTEM AND RESULT OF 4.2 MMOL/L OBTAINED ON A PROFESSIONAL METER WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE HOWEVER CUSTOMER NO LONGER HAS THE TEST STRIPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 113496 | ACCU-CHEK ® AVIVA TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 491459 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male |