MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-10 for COBAS 6800 05524245001 manufactured by Roche Molecular Systems, Inc.,.
[146372474]
For the customer's instrument (serial id (b)(4)), the local field service engineer replaced the entire front processing head, which is being returned for the investigation. The issue has been solved with these service actions and the instrument is running without issues with passing tightness check results and with no further evidence of leakage. The investigation is still on-going, and corrective and preventive actions will be implemented as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146372475]
A (b)(6) customer reported the generation of invalid runs with different tests on their cobas 6800 system (serial id (b)(4)). For a few runs, the negative control got a c02h1 flag which means "anomaly during calculation" since there was positive target detected in the negative control. This flag invalidates the samples and they must be repeat tested per the instructions for use. Provided images showed evidence of leakage as droplets were found in the processing module, on the heating station, and around the liquid waste station. A local field service engineer (fse) visited the site and performed the process head tightness check, which failed at multiple positions. The failed positions may cause the generation of the above referenced c02h1 error code. The fse replaced the entire front processing head. The issue has been solved with these service actions and the instrument is running without issues, with passing tightness check results and with no further evidence of leakage. No erroneous results were alleged, and no harm or injury was indicated through the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2019-00020 |
| MDR Report Key | 8599377 |
| Date Received | 2019-05-10 |
| Date of Report | 2019-07-10 |
| Date of Event | 2019-04-09 |
| Date Mfgr Received | 2019-04-18 |
| Date Added to Maude | 2019-05-10 |
| 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 |
| 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 | 2243471-06-06-2019-001-C |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COBAS 6800 |
| Generic Name | AUTOMATED BLOODBORNE PATHOGEN TEST EQUIPMENT |
| Product Code | MZA |
| Date Received | 2019-05-10 |
| Model Number | NA |
| Catalog Number | 05524245001 |
| Lot 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, INC., |
| Manufacturer Address | 1080 US HIGHWAY 202 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-10 |