FDA Adverse Event
Other
Summary report: N
ARCHITECT I2000SR ANALYZER
MDR report key: 969234
·
Received December 20, 2007
Report
- Report Number
- 1628664-2007-00597
- Event Type
- Other
- Date Received
- December 20, 2007
- Date of Event
- November 27, 2007
- Report Date
- November 27, 2007
- Manufacturer
- ABBOTT MANUFACTURING, INC.
- Product Code
- JJE
- PMA / PMN Number
- K983212
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
THE CUSTOMER STATED A PATIENT GENERATED A LOW B12 RESULT OF 112 PMOL/L ON THE ARCHITECT I2000SR. PER THE LABORATORY'S PROCEDURE, THE SAMPLE WAS RETESTED TWICE WITH RESULTS OF >2000 AND 132 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARCHITECT I2000SR ANALYZER | AUTOMATED IMMUNOASSAY ANALYZER | JJE | ABBOTT MANUFACTURING, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI YR | ARCHITECT B12 REAGENT LIST# 6C09-22 LOT# 55970M100 |