FDA Adverse Event
Malfunction
Summary report: N
ACCU-CHEK INFORM PLASMA TEST STRIPS
MDR report key: 964665
·
Received December 10, 2007
Report
- Report Number
- 1823260-2007-10622
- Event Type
- Malfunction
- Date Received
- December 10, 2007
- Date of Event
- October 4, 2007
- Report Date
- December 10, 2007
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- NBW
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE EVENT OCCURRED IN ANOTHER COUNTRY.
Description of Event or Problem · 1
REPORTER STATED THAT A PT'S BLOOD GLUCOSE WAS TESTED, USING THE INFORM SYSTEM, WITH A RESULT OF 2.7 MMOL/L. AN ADDITIONAL SAMPLE WAS IMMEDIATELY OBTAINED FROM THE PT AND, WHEN TESTED IN THE FACILITY'S LAB, MEASURED 2.0 MMOL/L. REPORTER DID NOT INDICATE IF PT WAS TREATED BASED ON THE VALUE OBTAINED ON THE INFORM SYSTEM. NO ADVERSE EVENT WAS REPORTED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCU-CHEK INFORM PLASMA TEST STRIPS | BLOOD GLUCOSE MONITORING TEST STRIPS | NBW | ROCHE DIAGNOSTICS | 549753 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR |