MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-21 for COBAS 8800 SYSTEM 5412722001 manufactured by Roche Molecular Systems, Inc..
[144241852]
For the customer's instrument (serial id sn-(b)(4)), all stop discs and o-rings were replaced on processing module b on the 15 january 2019, and are planned to be replaced on the processing module a. 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. Corrective and preventive actions will be implemented as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[144241853]
A (b)(6) field service engineer (fse) performed a tightness check on a customer's cobas 8800 system (serial id (b)(4)), which failed for processing module a, on (b)(6) 2019. Subsequent checks on this system passed on (b)(6) 2019. Review of customer-provided data showed one (1) p07p error code was generated for a sample processed on the cobas 8800 system processing module a on (b)(6) 2019; the error code p07p is indicative of a volume error during supernatant removal. When error codes are generated for samples, the samples are invalidated and need to be repeat tested per the instructions for use. 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 | 2243471-2019-00013 |
| MDR Report Key | 8440123 |
| Date Received | 2019-03-21 |
| Date of Report | 2019-03-21 |
| Date of Event | 2019-01-26 |
| Date Mfgr Received | 2019-02-21 |
| Date Added to Maude | 2019-03-21 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| 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 |
| 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 | 2019-03-21 |
| 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 | 2019-03-21 |
| 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 | 2019-03-21 |