FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 2942599
·
Received February 4, 2013
Report
- Report Number
- 1823260-2013-00661
- Event Type
- Malfunction
- Date Received
- February 4, 2013
- Date of Event
- January 23, 2013
- Report Date
- July 28, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K101299
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE AVIVA SYSTEM WITHIN 10 MINUTES: 500 MG/DL, 300 MG/DL, AND 200 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 46698 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 491308 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Male | AMLODIPINE 1X DAILY| BABY ASPIRIN 1X DAILY| CARVEDILOL 1X DAILY| FENOFIBRATE 1X DAILY| FINASTERIDE 1X DAILY| GLIPIZIDE 2X DAILY| LOVASTATIN 1X DAILY| TAMSULOSIN| UNSPECIFIED INSULIN PEN| TAMSULOSIN| FENOFIBRATE 1X DAILY| CARVEDILOL 1X DAILY| BABY ASPIRIN 1X DAILY| FINASTERIDE 1X DAILY| AMLODIPINE 1X DAILY| UNSPECIFIED INSULIN PEN| GLIPIZIDE 2X DAILY| LOVASTATIN 1X DAILY |