FDA Adverse Event
Malfunction
Summary report: N
LIPID PROFILE GLU CASSETTE
MDR report key: 25211082
·
Received May 18, 2026
Report
- Report Number
- 2027969-2026-00053
- Event Type
- Malfunction
- Date Received
- May 18, 2026
- Date of Event
- April 20, 2026
- Report Date
- May 18, 2026
- Manufacturer
- ALERE SAN DIEGO, INC.
- Product Code
- JGY
- UDI-DI
- 00893038002937
- PMA / PMN Number
- K120615
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
INVESTIGATION CONCLUSION PENDING COMPLETION OF INVESTIGATION ACTIVITIES.
Description of Event or Problem · 0
THE CUSTOMER REPORTED DISCREPANT RESULTS FOR TWO PATIENTS WHEN COMPARING THEIR CHOLESTECH LDX AND LABORATORY RESULTS. THE CUSTOMER PROVIDED THE FOLLOWING SET OF RESULTS FOR PATIENT 2 (IN MG/DL): (B)(6). THE PATIENT HAD BEEN FASTING PRIOR TO TESTING. NO NEGATIVE IMPACT TO THE PATIENT'S HEALTH WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 220019 | LIPID PROFILE GLU CASSETTE | CHOLESTECH LDX LIPID PROFILE+GLUCOSE TEST CASSETTE | JGY | ALERE SAN DIEGO, INC. | 97991 | 447122 | 00893038002937 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | CHOLESTECH LDX ANALYZER |