FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK AVIVA TEST STRIPS
MDR report key: 2161480
·
Received July 14, 2011
Report
- Report Number
- 1823260-2011-03733
- Event Type
- Malfunction
- Date Received
- July 14, 2011
- Date of Event
- July 4, 2011
- Report Date
- July 12, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN NETHERLANDS. MEDWATCH WITH IDENTIFIER (B)(6) IS FOR MOBILE SYSTEM, MEDWATCH WITH IDENTIFIER (B)(6) IS FOR AVIVA SYSTEM.
Description of Event or Problem · 1
CALLER REPORTED BLOOD GLUCOSE RESULTS OF 11.0 MMOL/L ON CUSTOMER'S MOBILE SYSTEM, 5.9 MMOL/L ON AVIVA SYSTEM WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE METERS AND STRIPS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK AVIVA TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 080 YR |