FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 3053038
·
Received April 11, 2013
Report
- Report Number
- 1823260-2013-02216
- Event Type
- Malfunction
- Date Received
- April 11, 2013
- Date of Event
- March 17, 2013
- Report Date
- July 29, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K101299
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
- 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: 119 MG/DL, 286 MG/DL, AND 132 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 |
|---|---|---|---|---|---|---|---|
| 155864 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 490849 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Female | ATROVENT| BISACODYL| CETIRIZINE HCL| CLONIDINE| DOCUSATE SODIUM| DOXEPIN HCL 2X DAILY| FUROSEMIDE 2X DAILY| GLIPIZIDE| METHADONE 1X DAILY| OMEPRAZOLE| POTASSIUM CHLORIDE 1X DAILY| PROAIR 6X DAILY| PROMETHAZINE 3X DAILY| SEREVENT DISKUS| SERTRALINE HCL 1X DAILY| OMEPRAZOLE| DOXEPIN HCL 2X DAILY| SERTRALINE HCL 1X DAILY| GLIPIZIDE| SEREVENT DISKUS| DOCUSATE SODIUM| METHADONE 1X DAILY| PROAIR 6X DAILY| ATROVENT| BISACODYL| CETIRIZINE HCL| CLONIDINE| FUROSEMIDE 2X DAILY| PROMETHAZINE 3X DAILY| POTASSIUM CHLORIDE 1X DAILY |