FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 3252282
·
Received July 29, 2013
Report
- Report Number
- 1823260-2013-04524
- Event Type
- Malfunction
- Date Received
- July 29, 2013
- Date of Event
- June 27, 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
- MS, 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
CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULTS OF 587 MG/DL AND 206 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 |
|---|---|---|---|---|---|---|---|
| 353787 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 491332 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Male | AMITRIPTYLINE HCL 1 X DAILY| ASPART HUMAN 4 X DAILY| ATORVASTATIN CALCIUM| BACLOFEN 3 X DAILY| C-PAP| HUMALOG 1 X DAILY| LISINOPRIL 1 X DAILY| OMEPRAZOLE 2 X DAILY| OXYBUTYNIN 2 X DAILY| VITAMIN D ERGOCALCIFEROL 1 X WEEK| WARFARIN| C-PAP| OXYBUTYNIN 2 X DAILY| OMEPRAZOLE 2 X DAILY| WARFARIN| HUMALOG 1 X DAILY| AMITRIPTYLINE HCL 1 X DAILY| ASPART HUMAN 4 X DAILY| ATORVASTATIN CALCIUM| BACLOFEN 3 X DAILY| LISINOPRIL 1 X DAILY| VITAMIN D ERGOCALCIFEROL 1 X WEEK |