FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 3883525
·
Received June 19, 2014
Report
- Report Number
- 1823260-2014-04461
- Event Type
- Malfunction
- Date Received
- June 19, 2014
- Date of Event
- May 24, 2014
- 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
- PA, 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. MEDWATCH WITH IDENTIFIER (B)(6) IS AVIVA SYSTEM 1, MEDWATCH WITH IDENTIFIER (B)(6) IS AVIVA SYSTEM 2.
Additional Manufacturer Narrative · 1
STRIPS NOT AVAILABLE FOR RETURN.
Description of Event or Problem · 1
CALLER REPORTED BLOOD GLUCOSE RESULTS OF 557 MG/DL ON AVIVA SYSTEM 1, 115 MG/DL ON AVIVA SYSTEM 2 WITHIN 10 MINUTES USING SAME FINGERSTICK. CUSTOMER USED SAME STRIPS FOR BOTH METERS. 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 |
|---|---|---|---|---|---|---|---|
| 361194 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 492174 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male | ASPIRIN| GLIMEPIRIDE| LISINOPRIL| STENT| STENT| ASPIRIN| LISINOPRIL| GLIMEPIRIDE |