FDA Adverse Event
Other
Summary report: N
DCA VANTAGE
MDR report key: 1531394
·
Received November 10, 2009
Report
- Report Number
- 1217157-2009-00023
- Event Type
- Other
- Date Received
- November 10, 2009
- Date of Event
- October 20, 2009
- Report Date
- October 20, 2009
- Manufacturer
- SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD.
- Product Code
- LCP
- PMA / PMN Number
- K071466
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THERE WAS NO IMPACT TO THE PTS CARE.
Description of Event or Problem · 1
CUSTOMER REPORTS DISCREPANT RESULTS BETWEEN TWO SHIPMENTS OF HBA1C ASSAY LOT 0791. THREE PTS WERE TESTED USING A TEST KIT FROM EACH SHIPMENT WITH THE FOLLOWING RESULTS: PATIENT 1: LOT 0791 (1ST SHIP): 5.9, LOT 0791 (2ND SHIP): 4.8. PATIENT 2: 7.0, 5.8. PATIENT 3: 6.0, 4.8. CUSTOMER FURTHER STATES THAT CONTROLS FOR THE 2ND SHIP WERE LOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DCA VANTAGE | DCA VANTAGE | LCP | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, LTD. | DCA VANTAGE | 0791 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |