FDA Adverse Event
Malfunction
Summary report: N
TRIAGE BNP TEST FOR BECKMAN COULTER
MDR report key: 3874853
·
Received April 25, 2014
Report
- Report Number
- 2027969-2014-00372
- Event Type
- Malfunction
- Date Received
- April 25, 2014
- Date of Event
- April 3, 2014
- Report Date
- April 3, 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
- MI, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THIS ISSUE IS BEING ADDRESSED UNDER (B)(4). INVESTIGATION PENDING.
Description of Event or Problem · 1
CUSTOMER REPORTED LOT TO LOT VARIABILITY BETWEEN 3 LOTS OF BCIS BNP REAGENT. CUSTOMER COMPARED HER PRIOR LOT 327048 TO LOTS 329599 AND LOT 331265 WHICH EXHIBITED A NEGATIVE BIAS. CUSTOMER RUNNING BIO-RAD CONTROLS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250625 | TRIAGE BNP TEST FOR BECKMAN COULTER | B-TYPE NATRIURETIC PEPTIDE TEST | NBC | ALERE SAN DIEGO, INC. | 98200 | 329599 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |