N
Patient 1
THE INVESTIGATION IS CURRENTLY ON-GOING. THE OUTCOME OF THIS INVESTIGATION WILL BE COMMUNICATED THROUGH A FOLLOW-UP REPORT. (B)(4).
MAUDE MDR 8304729
- MDR report key
- 8304729
- Report number
- 2243471-2019-00004
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-01-10
- Date received
- 2019-02-05
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- NA STACIE-ANN CREIGHTON
- Address
- 1080 US HWY 202 S NA BRANCHBURG NJ 08876 US
- Phone
- 908-908-9082
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | COBAS 8800 SYSTEM | AUTOMATED BLOODBORNE PATHOGEN TEST EQUIPMENT | ROCHE MOLECULAR SYSTEMS, INC | MZA | NA | 05412722001 | NA | R | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-02-05 | 0 |
Event Narratives#
D
Patient 1
A LOCAL FIELD SERVICE ENGINEER WENT ONSITE AND PERFORMED THE PROCESSING HEAD TIGHTNESS CHECK ON THE CUSTOMER'S COBAS 8800 SYSTEM, WHICH FAILED AT SEVERAL POSITIONS. EVIDENCE OF LEAKAGE WAS OBSERVED IN SPECIFIC AREAS OF THE COBAS 8800 SYSTEM. IT IS ASSUMED THAT THE LEAKAGE MIGHT BE LIQUID WASTE DROPLETS, IT COULD BE OBSERVED ON THE PROCESSING MODULE DECK, HEATING STATION, AND SEPARATION STATION. NO ERRONEOUS OR INVALID RESULTS WERE REPORTED, AND NO HARM OR INJURY WAS INDICATED.