FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA TEST STRIPS
MDR report key: 4102317
·
Received September 19, 2014
Report
- Report Number
- 1823260-2014-07185
- Event Type
- Malfunction
- Date Received
- September 19, 2014
- Date of Event
- August 24, 2014
- 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
- GM
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF 125 MG/DL AND 243 MG/DL WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 583563 | ACCU-CHEK ® AVIVA TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 491956 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Male |