FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA COMBO
MDR report key: 4192366
·
Received October 22, 2014
Report
- Report Number
- 1823260-2014-08137
- Event Type
- Malfunction
- Date Received
- October 22, 2014
- Date of Event
- September 22, 2014
- Report Date
- August 1, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.
Description of Event or Problem · 1
PATIENT'S MOTHER REPORTED HE EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS IN THE EVENING OF (B)(6) 2014. MOTHER STATED THE METER DOES NOT ALWAYS CORRECT THE ELEVATED BLOOD GLUCOSE LEVEL. NO ADVERSE EVENT WAS REPORTED. REQUESTED RETURN OF THE ALLEGED METER FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 672307 | ACCU-CHEK ® AVIVA COMBO | BLOOD GLUCOSE MONITORING DEVICE | NBW | ROCHE DIAGNOSTICS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 13 YR | Male |