MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-05 for COBAS 8800 SYSTEM 05412722001 manufactured by Roche Molecular Systems.
[104872090]
The investigation into this issue is currently on-going. The outcome of this investigation will be communicated through a follow-up report. The udi for the cobas 8800 system is (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[104872091]
A (b)(6) customer alleged invalid (p07p flag: volume error during supernatant removal) and discrepant hbv results for patient samples tested with the cobas? Hbv test for use on the cobas? 6800/8800 systems. The roche field service engineer visited the customer site and found a loose stop disc on the cobas 8800 system's processing transfer head, that could have caused the alleged discrepant results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2018-00004 |
| MDR Report Key | 7400749 |
| Date Received | 2018-04-05 |
| Date of Report | 2018-05-17 |
| Date of Event | 2018-03-06 |
| Date Mfgr Received | 2018-03-08 |
| Date Added to Maude | 2018-04-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 2018-04-05 |
| Model Number | NA |
| Catalog Number | 05412722001 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE MOLECULAR SYSTEMS |
| Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-05 |