FDA Adverse Event
Malfunction
Summary report: N
TRIAGE BNP TEST FOR BECKMAN COULTER
MDR report key: 3902772
·
Received May 9, 2014
Report
- Report Number
- 2027969-2014-00423
- Event Type
- Malfunction
- Date Received
- May 9, 2014
- Date of Event
- April 17, 2014
- Report Date
- April 17, 2014
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- NBC
- PMA / PMN Number
- K052789
- Removal / Correction Number
- 2027969-03/20/14-002C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE BCI BNP REAGENT LOT #329599 IS BEING REPORTED UNDER A SEPARATE MED WATCH MFR REPORT NUMBER 2027969-2014-00422. INVESTIGATION PENDING.
Description of Event or Problem · 1
CALLER ALLEGING TRIAGE BCIS BNP BIORAD (CXL15081 CXL15083 SHIFT IN RECOVERY, NOW BELOW THE MEAN BUT WITHIN 2SD. CUSTOMER HAS BOTH REAGENT LOT#S 329599 AND 331265 IN INVENTORY. SEES HIGH-OUT RECOVERY OF L1--AWAITING DATA. FAXED DATA INDICATES ALL RECOVERY IS WITHIN 1-2SD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281770 | TRIAGE BNP TEST FOR BECKMAN COULTER | B-TYPE NATRIURETIC PEPTIDE TEST | NBC | ALERE SAN DIEGO, INC. | 98200 | 331265 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | BIORAD CXL15081 CXL15083 |