FDA Adverse Event
Malfunction
Summary report: N
ACCESS® OSTASE QC KIT
MDR report key: 1971283
·
Received January 26, 2011
Report
- Report Number
- 2122870-2011-00144
- Event Type
- Malfunction
- Date Received
- January 26, 2011
- Date of Event
- December 28, 2010
- Report Date
- December 28, 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
- HK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
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 TO FREEZING AT -70 DEGREES CELCIUS. A 100% INSPECTION IS CONDUCTED WHEN THE VIAL LABELING PROCESS IS PERFORMED.
Description of Event or Problem · 1
...
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI), STATING THAT AN OSTASE QC VIAL WAS DAMAGED CAUSING THE CONTENTS TO LEAK WITHIN THE QC KIT BOX. 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 | NOT SUPPLIED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |