FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
MDR report key: 3031521
·
Received April 2, 2013
Report
- Report Number
- 1823260-2013-01997
- Event Type
- Malfunction
- Date Received
- April 2, 2013
- Date of Event
- March 5, 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
- TN, 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
CALLER REPORTED AVIVA SYSTEM BLOOD GLUCOSE RESULT OF 381 MG/DL, PROFESSIONAL SYSTEM RESULT OF 121 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 |
|---|---|---|---|---|---|---|---|
| 135245 | ACCU-CHEK ® AVIVA PLUS TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 491311 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Male | ACTOS| ALBUTEROL| ASPIRIN| ATORVASTATIN| BREATHING MACHINE INHALER| CENTRUM SILVER VITAMINS| GEMFIBROZIL| GLIPIZIDE| HYDROCODONE| LISINOPRIL| METFORMIN| MORPHINE| OMEPRAZOLE| PROMETHAZINE| VITAMIN D| XANAX| ALBUTEROL| XANAX| MORPHINE| ASPIRIN| GEMFIBROZIL| ATORVASTATIN| GLIPIZIDE| PROMETHAZINE| BREATHING MACHINE INHALER| METFORMIN| ACTOS| OMEPRAZOLE| CENTRUM SILVER VITAMINS| HYDROCODONE| VITAMIN D| LISINOPRIL |