FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 2992002
·
Received March 7, 2013
Report
- Report Number
- 1823260-2013-01361
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Date of Event
- February 10, 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
- PA, 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: 503 MG/DL, 287 MG/DL, 175 MG/DL, AND 206 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 |
|---|---|---|---|---|---|---|---|
| 97398 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 490795 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Male | AMLODIPINE BESYLATE| ASPART| BABY ASPIRIN| BUPROPION HCL| CALCIUM MAGNESIUM ZINC| CENTRUM SILVER| HCTZ TRIAMTERENE| LANTUS| LISINOPRIL| LUTEIN| METFORMIN HCL| NORWEGIAN COD LIVER OIL| ROSUVASTATIN CA| VITAMIN C| VITAMIN D| LANTUS| LISINOPRIL| NORWEGIAN COD LIVER OIL| VITAMIN D| AMLODIPINE BESYLATE| BABY ASPIRIN| CALCIUM MAGNESIUM ZINC| CENTRUM SILVER| VITAMIN C| BUPROPION HCL| ROSUVASTATIN CA| METFORMIN HCL| ASPART| LUTEIN| HCTZ TRIAMTERENE |