FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK ® COMFORT CURVE TEST STRIPS
MDR report key: 2086007
·
Received May 11, 2011
Report
- Report Number
- 1823260-2011-02558
- Event Type
- Malfunction
- Date Received
- May 11, 2011
- Date of Event
- April 26, 2011
- Report Date
- May 19, 2011
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFR
- PMA / PMN Number
- K010362
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. OTHER: NA.
Description of Event or Problem · 1
CALLER FROM INFORM SYSTEM USER FACILITY REPORTED NEONATE PATIENT BLOOD GLUCOSE RESULTS: (B)(6) 2011, 9:07 AM, METER RESULT WAS 26 MG/DL (B)(6) 2011, 9:29 AM, METER RESULT WAS 45 MG/DL (B)(6) 2011, 9:29 AM, LAB RESULT WAS 27 MG/DL (B)(6) 2011, 9:59 AM, METER RESULT WAS 45 MG/DL (B)(6) 2011, 11:06 AM, METER RESULT WAS 55 MG/DL (B)(6) 2011, 11:06 AM, LAB RESULT WAS 39 MG/DL NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE STRIPS.
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 | 551485 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 0 DA |