FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
MDR report key: 2840980
·
Received November 20, 2012
Report
- Report Number
- 1823260-2012-05911
- Event Type
- Malfunction
- Date Received
- November 20, 2012
- Date of Event
- October 26, 2012
- Report Date
- November 26, 2012
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 THE FOLLOWING READINGS WERE OBTAINED ON A PATIENT USING TWO INFORM SYSTEMS WITHIN 10 MINUTES: 149 MG/DL (INFORM SYSTEM 1), 310 MG/DL (INFORM SYSTEM 2), AND 310 MG/DL (INFORM SYSTEM 1). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND 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 | 551771 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 054 YR | ALPRAZOLAM| BISMUTH SUBSALICYLATE| ONDENSENTRON HCL| POTASSIUM CHLORIDE| INSULIN - HUMAN REGULAR| HYDROCORTISONE| ALBUTEROL/IPRATROPIUM| CHOLESTYRAMINE RESIN| VENTILATOR| OMEPRAZOLE| FUROSEMIDE| ENOXAPARIN SODIUM| DOCUSATE SODIUM |