FDA Adverse Event
Malfunction
Summary report: N
ACCESS® OSTASE QC KIT
MDR report key: 1963108
·
Received January 18, 2011
Report
- Report Number
- 2122870-2011-00096
- Event Type
- Malfunction
- Date Received
- January 18, 2011
- Date of Event
- December 22, 2010
- Report Date
- December 22, 2010
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJX
- PMA / PMN Number
- K994277
- Removal / Correction Number
- Z-2605-6-2011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION OF DAMAGED OSTASE QC VIALS WAS CONDUCTED AT BECKMAN COULTER (B)(4). THE INVESTIGATION DETERMINED THE GLASS VIALS ARE NOT COMPATIBLE AT FREEZING AT -70 DEGREES CELCIUS. A 100% INSPECTION IS CONDUCTED WHEN THE VIAL LABELING PROCESS IS PERFORMED.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
...
Description of Event or Problem · 1
BECKMAN COULTER (B)(4) REPORTED A DAMAGED OSTASE QC VIAL WHICH CAUSED THE CONTENTS TO LEAK. THERE WAS NO REPORT OF AFFECT TO PATIENTS OR END USERS IN CONNECTION WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACCESS® OSTASE QC KIT | SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) | JJX | BECKMAN COULTER INC. | NA | 020420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |