ELECSYS CMV IGG
Report
- Report Number
- 1823260-2022-01184
- Event Type
- Malfunction
- Date Received
- April 26, 2022
- Date of Event
- March 1, 2022
- Report Date
- June 6, 2022
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- LFZ
- UDI-DI
- 04015630940172
- PMA / PMN Number
- K131605
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION IS ONGOING.
THE PATIENT'S SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. BASED ON THE PROVIDED INFORMATION, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
THE INITIAL REPORTER RECEIVED QUESTIONABLE ELECSYS CMV IGG RESULTS FOR ONE PATIENT TESTED ON A COBAS 8000 E 801 MODULE SERIAL NUMBER (B)(4). THE PATIENT HAD TWO SAMPLES COLLECTED. THE PATIENT'S ELECSYS CMV IGG RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE PATIENT'S SAMPLES WERE REPEATED ON A VIDAS ANALYZER AND A LIAISON ANALYZER. ON (B)(6) 2022, THE PATIENT'S FIRST SAMPLE WAS COLLECTED. THE PATIENT'S ELECSYS CMV IGG RESULT WAS 2.5 U/ML POSITIVE. THE PATIENT'S VIDAS CMV IGG RESULT WAS 0.135 UA/ML NEGATIVE. ON (B)(6) 2022, THE PATIENT'S SECOND SAMPLE WAS COLLECTED. THE PATIENT'S ELECSYS CMV IGG RESULT WAS "<1" U/ML NEGATIVE. THE PATIENT'S VIDAS CMV IGG RESULT WAS 19 UA/ML POSITIVE. THE PATIENT'S LIAISON CMV IGG RESULT WAS 63 U/ML POSITIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1528753 | ELECSYS CMV IGG | ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS | LFZ | ROCHE DIAGNOSTICS | NA | 56805401 | 04015630940172 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |