FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® AVIVA TEST STRIPS
MDR report key: 1801393
·
Received August 16, 2010
Report
- Report Number
- 1823260-2010-04833
- Event Type
- Malfunction
- Date Received
- August 16, 2010
- Date of Event
- August 8, 2010
- Report Date
- August 27, 2010
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K043474
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
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 BLOOD GLUCOSE RESULTS OF 578 MG/DL AND 181 MG/DL WITHIN 10 MINUTES ON THE ACCU-CHEK SYSTEM. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.
Description of Event or Problem · 1
PT SELF TESTER REPORTED DISCREPANT RESULTS. PT'S TARGET THERAPEUTIC RANGE IS 2.5-3.5.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® AVIVA TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 302749 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 081 YR | METFORMIN| DIGOXIN| DILTIAZEM| GLYPIZIDE |