FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA TEST STRIPS
MDR report key: 4190255
·
Received October 21, 2014
Report
- Report Number
- 1823260-2014-08098
- Event Type
- Malfunction
- Date Received
- October 21, 2014
- Date of Event
- September 21, 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
- SP
- 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. REFERENCE THE FOLLOWING MEDWATCHES WITH PATIENT IDENTIFIERS FOR THE FOLLOWING SYSTEMS: (B)(6) - AVIVA EXPERT - SYSTEM 1, (B)(6) - AVIVA - SYSTEM 2. DEVICE WILL NOT BE RETURNED.
Description of Event or Problem · 1
CUSTOMER ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT METERS, WITHIN 10 MINUTES: 404 MG/DL (AVIVA EXPERT, SYSTEM 1) AND 69 MG/DL (AVIVA, SYSTEM 2). CUSTOMER WAS SENT TO THE ER BY THE MEDICAL TEAM AND ADMITTED FOR 2 HOURS; NO TREATMENT WAS RECEIVED. NO STRIPS WILL BE RETURNED. NO PRODUCT WILL BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 668675 | ACCU-CHEK ® AVIVA TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 4 YR | Male |