FDA Adverse Event
Malfunction
Summary report: N
ALBP ALBUMIN BCP
MDR report key: 16531768
·
Received March 13, 2023
Report
- Report Number
- 1823260-2023-00792
- Event Type
- Malfunction
- Date Received
- March 13, 2023
- Date of Event
- February 22, 2023
- Report Date
- April 10, 2023
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- CJW
- UDI-DI
- 04015630928064
- PMA / PMN Number
- K844426
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
QUALITY CONTROLS WERE ACCEPTABLE ON THE DAY OF THE EVENT. THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE ISSUE IS CONSISTENT WITH INCORRECT PRE-ANALYTIC SAMPLE HANDLING.
Additional Manufacturer Narrative · 0
CALIBRATION DATA WAS OK.
Description of Event or Problem · 0
THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR ONE PATIENT SAMPLE TESTED WITH ALBP ALBUMIN BCP ON A COBAS 8000 C702 MODULE (SERIAL NUMBER (B)(4). NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE SAMPLE INITIALLY RESULTED IN AN ALBUMIN VALUE OF 82.9 G/L AND IT REPEATED AS 40.0 G/L.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1649887 | ALBP ALBUMIN BCP | BROMCRESOL PURPLE DYE-BINDING, ALBUMIN | CJW | ROCHE DIAGNOSTICS | ALB BCP | 65252401 | 04015630928064 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male |