FDA Adverse Event
Malfunction
Summary report: N
LEICA TP1020
MDR report key: 20974867
·
Received December 19, 2024
Report
- Report Number
- 8010478-2024-00017
- Event Type
- Malfunction
- Date Received
- December 19, 2024
- Date of Event
- November 20, 2024
- Report Date
- February 17, 2025
- Manufacturer
- LEICA BIOSYSTEMS NUSSLOCH GMBH
- Product Code
- IEO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LU
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 0
AN INVESTIGATION OF THE INCIDENT IS CURRENTLY UNDERWAY AND A FOLLOW UP WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE FOLLOWING THE INVESTIGATION.
Additional Manufacturer Narrative · 0
ON JANUARY 20, 2025, A LEICA BIOSYSTEMS SERVICE ENGINEER VISITED THE CUSTOMER SITE AS PER CUSTOMER REQUEST. A STANDARD PREVENTIVE MAINTENANCE WAS CARRIED OUT AT THE TIME OF THE VISIT. NO TECHNICAL PROBLEMS WERE FOUND. THE REAGENTS WERE FOUND TO BE CONTAMINATED AND THE CUSTOMER WAS ADVISED TO EXCHANGE ALL REAGENTS BEFORE RETURNING THE INSTRUMENT TO REGULAR USE.
Description of Event or Problem · 0
ON 20 NOVEMBER 2024 LEICA BIOSYSTEMS RECEIVED THE CONFIRMATION, THAT THE CUSTOMER EXPERIENCED SUBOPTIMAL TISSUE PROCESSING ON THEIR TP1020, TISSUE PROCESSOR. AS A RESULT THE TISSUE WAS UNDIAGNOSABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2115158 | LEICA TP1020 | PROCESSOR, TISSUE, AUTOMATED | IEO | LEICA BIOSYSTEMS NUSSLOCH GMBH | LEICA TP1020 (SINGLE LOAD) WITH FUME CONTR(100-240V/50-60HZ) |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |