MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-09 for COBAS 6800 SYSTEM 05524245001 manufactured by Roche Molecular Systems, Inc..
[129162971]
Previous investigative testing showed that the tightness check for a processing head will fail when the stop disk is very loose and significantly less than 2 ncm torque (recommended torque documented in the instrument service documentation is 15 ncm). No leakage from the pipette tips was observed when the stop disks were tightened between 2 to 15 ncm using a torque wrench. The torque measurement (force) for the loose stop disk associated with the failed tightness check on the customer's cobas 6800 system is unknown. The error flags generated in this case could be a result of the leakage caused by the loose stop discs. The root cause investigation is currently on-going, and corrective and preventive actions will be implemented as appropriate. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[129162972]
A customer from (b)(6) reported the generation of an invalid cobas mpx positive control [mpx o (+) control] due to an error flag (c02h1). When reviewing several runs within the customer-provided data, it was identified that several wells, containing samples or controls, had the error code p07p, which is indicative of a volume error during supernatant removal. The roche field service engineer visited the customer site and found a failed result for process head tightness check with some loose stop discs on the cobas 6800 system's processing transfer heads, that were likely the cause for the generation of the error codes. The roche field service engineer replaced all stop discs & o-rings on this instrument processing transfer head. There is no allegation on discrepant donor sample results. When error codes are generated for the cobas mpx controls, the test run is invalidated and all donor samples included in the test run need to be repeat tested per the instructions for use. When the p0p7 error code is generated for a donor sample, the donor sample needs to be repeat tested per the instructions for use. No harm or injury was reported through the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2018-00014 |
| MDR Report Key | 8055672 |
| Date Received | 2018-11-09 |
| Date of Report | 2018-11-09 |
| Date of Event | 2018-09-26 |
| Date Mfgr Received | 2018-10-31 |
| Date Added to Maude | 2018-11-09 |
| 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 SYSTEM |
| Generic Name | AUTOMATED BLOODBORNE PATHOGEN TEST EQUIPMENT |
| Product Code | MZA |
| Date Received | 2018-11-09 |
| 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 | 2018-11-09 |