FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
MDR report key: 1963046
·
Received January 18, 2011
Report
- Report Number
- 1823260-2011-00269
- Event Type
- Malfunction
- Date Received
- January 18, 2011
- Date of Event
- July 6, 2010
- Report Date
- February 2, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
UNABLE TO REST BECAUSE AN EMPTY VIAL WAS RETURNED.
Additional Manufacturer Narrative · 1
WILL NOT BE RETURNED TO MANUFACTURER.
Description of Event or Problem · 1
CUSTOMER REPORTEDLY RECEIVED RESULTS OF 187 MG/DL AND 102 MG/DL WITHIN 10 MINUTES ON THE ADVANTAGE SYSTEM USING COMFORT CURVE TEST STRIPS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE HOWEVER CUSTOMER NO LONGER HAS THE TEST STRIPS; REPLACEMENT WAS SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK ® COMFORT CURVE TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | LFR | ROCHE DIAGNOSTICS | NA | 550967 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 077 YR | ASPIRIN| METFORMIN |