MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-14 for COBAS 8800 SYSTEM 05412722001 NA manufactured by Roche Molecular Systems, Inc..
[120715551]
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 8800 system is unknown. The false positive results reported 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
[120715552]
A (b)(6) customer alleged discrepant (b)(6) 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 failed result for process head tightness check with some loose stop discs on the cobas 8800 system's processing transfer heads, that could have caused the alleged discrepant results. No harm or injury was reported through the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2018-00011 |
| MDR Report Key | 7878750 |
| Date Received | 2018-09-14 |
| Date of Report | 2018-09-14 |
| Date of Event | 2018-08-14 |
| Date Mfgr Received | 2018-09-03 |
| Date Added to Maude | 2018-09-14 |
| 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 |
| 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 | 2018-09-14 |
| Model Number | 05412722001 |
| Catalog Number | NA |
| 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 | 2018-09-14 |