FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 3943336
·
Received July 18, 2014
Report
- Report Number
- 1823260-2014-05337
- Event Type
- Malfunction
- Date Received
- July 18, 2014
- Date of Event
- June 24, 2014
- 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
- NJ, 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
CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF 341 MG/DL, 196 MG/DL, 149 MG/DL, 151 MG/DL, AND 138 MG/DL WITHIN 10 MINUTES. NO ADVERSE EVENT WAS REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 423284 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 492221 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Male | AMLODIPINE BESYLATE| CYANOCOBALAMIN| FUROSEMIDE| HYDRALAZINE| LANTUS| LISINOPRIL| METOPROLOL TARTRATE| NOVOLOG| OMEPRAZOLE| PRAVASTATIN| AMLODIPINE BESYLATE| LANTUS| FUROSEMIDE| NOVOLOG| HYDRALAZINE| CYANOCOBALAMIN| LISINOPRIL| OMEPRAZOLE| METOPROLOL TARTRATE| PRAVASTATIN |