FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 3112454
·
Received May 14, 2013
Report
- Report Number
- 1823260-2013-02951
- Event Type
- Malfunction
- Date Received
- May 14, 2013
- Date of Event
- April 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
- CA, 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: 560 MG/DL AND 223 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 |
|---|---|---|---|---|---|---|---|
| 212963 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 491375 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Female | ASPIRIN| CINNAMON TABLET| LEVEMIR| LISINOPRIL| NIACIN| NOVOLOG| SIMVASTIN| UNSPECIFIED DIABETIC VITAMIN| CINNAMON TABLET| NIACIN| LEVEMIR| NOVOLOG| LISINOPRIL| SIMVASTIN| ASPIRIN| UNSPECIFIED DIABETIC VITAMIN |