FDA Adverse Event
Malfunction
Summary report: N
SOLANA SARS-COV-2 ASSAY (LYO MMX)
MDR report key: 16358068
·
Received February 10, 2023
Report
- Report Number
- 0002024674-2023-00398
- Event Type
- Malfunction
- Date Received
- February 10, 2023
- Date of Event
- January 16, 2023
- Report Date
- March 16, 2023
- Manufacturer
- QUIDEL CORPORATION
- Product Code
- QJR
- PMA / PMN Number
- EUA203087
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
INVESTIGATION CONCLUSION: TO BE DETERMINED. ROOT CAUSE: TO BE DETERMINED. SOURCE: PHONE.
Additional Manufacturer Narrative · 0
UPDATES TO MANUFACTURERS NARRATIVE: INVESTIGATION CONCLUSION: INVESTIGATION CONCLUSION: QUIDELORTHO PERSONEL WAS SENT ONSITE FOR FURTHER TROUBLESHOOTING AND TRAINING WHICH FOUND ISSUES WITH CONTAMINATION, FAULTY EQUIPMENT, AND USER ERROR. ISSUE IS NO LONGER PRESENT SINCE ONSITE TRAINING VISIT AND TERMINATION OF EMPLOYEE CAUSING TECHNICAL ISSUES. ROOT CAUSE: CUSTOMER PROCEDURAL ERROR AND FAULTY EQUIPMENT. SOURCE: PHONE.
Description of Event or Problem · 0
CUSTOMER REPORTING ALL SAMPLES POSITIVE FOR ONE OF THEIR SARS PLATES/RUNS. CONTAMINATION AND/OR TECHNICAL ERROR IS SUSPECT. INVESTIGATION IS CURRENTLY ON GOING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 47596 | SOLANA SARS-COV-2 ASSAY (LYO MMX) | SOLANA SARS-COV-2 ASSAY (LYO MMX) | QJR | QUIDEL CORPORATION | 225666 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |