MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-01 for COBAS 6800 05524245001 manufactured by Roche Molecular Systems, Inc..
[146372822]
During the investigation, the returned o-rings were inspected and showed a decrease in size. The investigation is on-going, and corrective and preventive actions will be implemented, as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[146372823]
A uk customer reported the generation of invalid cobas mpx run batches (error codes c02h1, c02h2 and c02h3) due to internal control not being amplified within the negative control. In addition to the error codes, a review of the cobas 6800 systems trace files showed the generation of the p07p flag, which is indicative of a volume error during supernatant removal. A local field service engineer performed an instrument tightness check, which passed, and there no signs of droplets or evidence of leakage on the instrument deck. The o-rings of the cobas 6800 system's front processing head were still proactively replaced for all positions, and subsequently returned for investigation. As a result of these service actions, the cobas 6800 system is running without issues. From the investigation, some of the returned o-rings showed a decreased size upon inspection. No harm or erroneous results were alleged. Invalid run batches must be repeated per the product labeling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2019-00018 |
| MDR Report Key | 8570500 |
| Date Received | 2019-05-01 |
| Date of Report | 2019-05-01 |
| Date of Event | 2019-03-07 |
| Date Mfgr Received | 2019-04-04 |
| Date Added to Maude | 2019-05-01 |
| 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 | 2019-05-01 |
| 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 S NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-01 |