FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA COMBO
MDR report key: 3891133
·
Received June 24, 2014
Report
- Report Number
- 1823260-2014-04627
- Event Type
- Malfunction
- Date Received
- June 24, 2014
- Date of Event
- March 26, 2014
- Report Date
- July 29, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- CGD
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(4).
Description of Event or Problem · 1
CALLER REPORTED DISPLAY OF METER HAS SEVERAL THIN VERTICAL LINES. CALLER STATED MEASUREMENT RESULTS WERE NOT AFFECTED. PRELIMINARY EVALUATION FOUND THE METER FOR DISPLAY DEFECT; TWO THIN AND ONE THICK LINE APPEAR ON THE MIDDLE OF THE METER SCREEN. EVALUATION FOUND THAT THE LOCATION OF THE LINE ON THE DISPLAY DOES DISTORT THE DIGIT DURING THE SIMULATION TEST, THEREFORE MISINTERPRETATION IS POSSIBLE. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED METER FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 367479 | ACCU-CHEK ® AVIVA COMBO | BLOOD GLUCOSE MONITORING DEVICE | CGD | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Female |