FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA TEST STRIPS
MDR report key: 2982688
·
Received February 28, 2013
Report
- Report Number
- 1823260-2013-01217
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- February 6, 2013
- Report Date
- July 28, 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 MOBILE 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 1 MINUTE: 18.9 MMOL/L (MOBILE) AND 9.0 MMOL/L (AVIVA NANO). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88369 | ACCU-CHEK ® AVIVA TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Female | HUMALOG - 3X'S A DAY| LANTUS - 2X'S A DAY| HUMALOG - 3X'S A DAY| LANTUS - 2X'S A DAY |