FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
MDR report key: 2870336
·
Received December 12, 2012
Report
- Report Number
- 1823260-2012-06298
- Event Type
- Malfunction
- Date Received
- December 12, 2012
- Date of Event
- November 19, 2012
- Report Date
- January 25, 2013
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.
Description of Event or Problem · 1
CALLER STATES THAT A PATIENT REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON AN INFORM METER, COMPARED TO LAB RESULTS, WITHIN 10 MINUTES: 203 MG/DL (INFORM METER) AND 462 MG/DL (LAB). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECTED DEVICE AND STRIPS; HOWEVER, CUSTOMER INDICATED THERE MAY BE NO STRIPS LEFT TO RETURN. 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 | 551741 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 050 YR | HYDROCHLOROTHIAZIDE| GLIMEPIRIDE - 1X A DAY| LANTUS - 1X A DAY |