FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 3171072
·
Received June 14, 2013
Report
- Report Number
- 1823260-2013-03609
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Date of Event
- May 16, 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
- IL, 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 66 MG/DL, 120 MG/DL, 187 MG/DL, AND 92 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 |
|---|---|---|---|---|---|---|---|
| 270823 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 491364 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male | ASPIRIN| BLOOD PRESSURE MONITOR| CALCIUM| CLONIDINE| COZAAR| CRESTOR| DILTIAZEM| DOXAZOSIN| FISH OIL| FUROSEMIDE| GABAPENTIN| GARLIC| GLIMEPIRIDE| ISOSORBIDE| METFORMIN| MULTIVITAMIN| PLAVIX| TEMPORAL ARTERY THERMOMETER| VALIUM 2XDAY| VITAMIN C| ZETIA| GARLIC| ASPIRIN| DOXAZOSIN| FUROSEMIDE| DILTIAZEM| COZAAR| FISH OIL| CALCIUM| MULTIVITAMIN| TEMPORAL ARTERY THERMOMETER| BLOOD PRESSURE MONITOR| ZETIA| VITAMIN C| CRESTOR| VALIUM 2XDAY| GLIMEPIRIDE| ISOSORBIDE| PLAVIX| GABAPENTIN| METFORMIN| CLONIDINE |