FDA Adverse Event
Malfunction
Summary report: N
ANALYTICAL E MODULE
MDR report key: 1569601
·
Received December 2, 2009
Report
- Report Number
- 1823260-2009-08147
- Event Type
- Malfunction
- Date Received
- December 2, 2009
- Date of Event
- November 19, 2009
- Report Date
- December 2, 2009
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K961481
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
ROCHE FIELD PERSONNEL RAN A CKMB REFERENCE RANGE STUDY FOR THE USER BY RUNNING 72 PT SAMPLES ON NEW REAGENT LOT 155150 AND ON THE OLD REAGENT LOT NUMBER 153686. THE RESULTS FOR ALL PT SAMPLES WERE DISCREPANT. NO RESULTS WERE REPORTED. NO SERVICE VISIT WAS SCHEDULED AS A REAGENT BULLETIN, WHICH INCLUDES THE NEW LOT USED BY THE CUSTOMER, HAS BEEN ISSUED COMMUNICATING THE CKMB REAGENT HAS BEEN RESTANDARDIZED. ALL RESULTS ARE IN NG PER ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANALYTICAL E MODULE | IMMUNOCHEMISTRY ANALYZER - JJE | JJE | ROCHE DIAGNOSTICS | E MODULE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |