MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-26 for COBAS 8800 SYSTEM 5412722001 manufactured by Roche Molecular Systems, Inc..
[139996022]
For the customer's instrument (serial id (b)(4)), the stop discs and o-rings at the failing positions were replaced on processing module b. The material has been requested back for further investigation with the supplier. The droplets observed around the heating stations were cleaned by the local field service engineer. The issue has been solved with these service actions and the instrument is running without issues with passing tightness check results and with no evidence of leakage. Corrective and preventive actions will be implemented as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[139996023]
A (b)(4) field service engineer (fse) performed a tightness check on a customer's cobas 8800 system (serial id (b)(4)), which failed for processing module b. The fse replaced the stop discs and o-rings at the failing positions, then re-performed the tightness check, which passed. Additionally, images on the processing module decks were provided and showed evidence of leakage/droplets on the front heating station. No harm or injury was alleged within the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2019-00014 |
| MDR Report Key | 8451593 |
| Date Received | 2019-03-26 |
| Date of Report | 2019-03-26 |
| Date of Event | 2018-12-17 |
| Date Mfgr Received | 2019-03-18 |
| Date Added to Maude | 2019-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | NA STACIE-ANN CREIGHTON |
| Manufacturer Street | 1080 US HWY 202 S NA |
| Manufacturer City | BRANCHBURG NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 9082537112 |
| Manufacturer G1 | ROCHE INTERNATIONAL ROTKREUZ |
| Manufacturer Street | FORRENSTRASSE 2 NA |
| Manufacturer City | ROTKREUZ 6343 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 6343 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COBAS 8800 SYSTEM |
| Generic Name | AUTOMATED BLOODBORNE PATHOGEN TEST EQUIPMENT |
| Product Code | MZA |
| Date Received | 2019-03-26 |
| Model Number | NA |
| Catalog Number | 5412722001 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
| Brand Name | COBAS 8800 SYSTEM |
| Generic Name | AUTOMATED BLOODBORNE PATHOGEN TEST EQUIPMENT |
| Product Code | MZA |
| Date Received | 2019-03-26 |
| Model Number | NA |
| Catalog Number | 5412722001 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS, INC. |
| Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-26 |