MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for COBAS 6800 05524245001 manufactured by Roche Molecular Systems, Inc..
[146372568]
For the customer's instrument, the local field service engineer (fse) went onsite, and found several positions of the processing transfer head front failing the tightness check as well as evidence of droplets/leakage. 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. Corrective and preventive actions will be implemented as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146372569]
The customer reported a high rate of invalid results with the cobas mpx test, and review of instrument files showed the generation of p07p flags, which is indicative of a volume error during supernatant removal. The local field service engineer (fse) went onsite, and found several positions of the processing transfer head front failing the tightness check as well as evidence of droplets/leakage. After replacing the o-rings & stop discs of these positions the check passed. The site has reported the invalid rate has decreased. There was no allegation of erroneous results, harm, or injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2019-00019 |
| MDR Report Key | 8578567 |
| Date Received | 2019-05-03 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-03-18 |
| Date Mfgr Received | 2019-04-12 |
| Date Added to Maude | 2019-05-03 |
| 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 | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COBAS 6800 |
| Generic Name | AUTOMATED BLOODBORNE PATHOGEN TEST EQUIPMENT |
| Product Code | MZA |
| Date Received | 2019-05-03 |
| Model Number | NA |
| Catalog Number | 05524245001 |
| 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 | 2019-05-03 |