FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® SENSOR COMFORT TEST STRIPS
MDR report key: 1971982
·
Received January 27, 2011
Report
- Report Number
- 1823260-2011-00499
- Event Type
- Malfunction
- Date Received
- January 27, 2011
- Date of Event
- January 21, 2011
- Report Date
- April 8, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED RESULTS OF 500 MG/DL AND 70 - 80 MG/DL WITHIN 10 MINUTES ON THE COMFORT SYSTEM USING SENSOR COMFORT TEST STRIPS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® SENSOR COMFORT TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 571424 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |