FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK COMFORT CURVE TEST STRIPS
MDR report key: 1110125
·
Received August 14, 2008
Report
- Report Number
- 1823260-2007-05125
- Event Type
- Malfunction
- Date Received
- August 14, 2008
- Date of Event
- May 29, 2007
- Report Date
- June 12, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER ALLEGED WHEN OPENING A NEW VIAL OF COMFORT CURVE TEST STRIPS USED IN THE BLOOD GLUCOSE MONITORING ACCU-CHEK SYSTEM, TWO OF THE STRIPS WERE BLOODY AND THERE WAS A DROP OF BLOOD ON THE OUTSIDE OF THE VIAL. REPORTER STATED SHE DID NOT USE THE TEST STRIPS, HOWEVER, CONTACTED THE DOMESTIC MANUFACTURER AND THE SUPPLIER. NO REPORT OF ANY OTHER ACTIONS OR TREATMENT. UPON RETURN OF THE REQUESTED PRODUCT, REPLACEMENT PRODUCT 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 | LFR | ROCHE DIAGNOSTICS | 549627 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | GLUCOVANCE 500MG 4 PILLS ONCE DAILY |