FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
MDR report key: 1905184
·
Received November 22, 2010
Report
- Report Number
- 1823260-2010-06936
- Event Type
- Malfunction
- Date Received
- November 22, 2010
- Date of Event
- November 9, 2010
- Report Date
- January 11, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 2. (B)(6).
Description of Event or Problem · 1
REPORTER ALLEGED THE PATIENT A RESULT OF 457 MG/DL ON INFORM SYSTEM 1 COMPARED BACK TO BACK WITH A RESULT OF 35 MG/DL ON INFORM SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. REPORTER STATED THAT THE STAFF ADMINISTERED D50. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.
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 | 551327 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | REGULAR INSULIN| DIALYSIS CATHETER, LEFT ARM |