FDA Adverse Event
Malfunction
Summary report: N
ELECSYS IGE II IMMUNOASSAY
MDR report key: 19069994
·
Received April 9, 2024
Report
- Report Number
- 1823260-2024-01074
- Event Type
- Malfunction
- Date Received
- April 9, 2024
- Date of Event
- March 1, 2024
- Report Date
- April 19, 2024
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JHR
- PMA / PMN Number
- K061970
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative · 0
THE COBAS E411 RACK SERIAL NUMBER WAS (B)(6).
Description of Event or Problem · 0
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS IGE II IMMUNOASSAY RESULTS FROM THE COBAS E411 RACK ANALYZER. THE INITIAL RESULT WAS 0.5 IU/ML. ON (B)(6) 2024, THE RESULT FROM ANOTHER LABORATORY WAS "ALLERGY(+)". THE CLINICIAN INQUIRED ABOUT THE RESULTS AND THE CUSTOMER REPEATED THE ORIGINAL SAMPLE WITH A RESULT OF 2500 IU/ML.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 608143 | ELECSYS IGE II IMMUNOASSAY | IMMUNOGLOBULIN E ASSAY | JHR | ROCHE DIAGNOSTICS | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |