FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
MDR report key: 1902646
·
Received November 18, 2010
Report
- Report Number
- 1823260-2010-06833
- Event Type
- Malfunction
- Date Received
- November 18, 2010
- Date of Event
- November 8, 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
- PA, US
- Reporter Occupation
- PATIENT
Narratives
Additional Manufacturer Narrative · 1
THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN SYSTEM 1. (B)(6).
Description of Event or Problem · 1
REPORTER ALLEGED OBTAINING A RESULT OF 74 MG/DL ON AVIVA SYSTEM 1 COMPARED BACK TO BACK WITH THE RESULTS OF 20 MG/DL, LO (LESS THAN 10 MG/DL) AND 78 MG/DL ON AVIVA SYSTEM 2 WHEN TESTING WAS PERFORMED WITHIN 10 MINUTES. NO 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 | 551357 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 062 YR | SIMVASTATIN (DAILY)| ISOSORBIDE (TWICE DAILY)| BABY ASPIRIN (TWICE DAILY)| "LETHARTON" (TWICE DAILY)| TYLENOL (DAILY OR AS NEEDED)| HYDROCHLOROTHIAZIDE| METOPROLOL TARTRATE (3 TIMES DAILY)| GABAPENTIN (TWICE DAILY)| LANTUS (NIGHTLY)| HUMALOG (DAILY) |