MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-20 for COBAS 6800 SYSTEM 5524245001 manufactured by Roche Molecular Systems, Inc..
[137129500]
The investigation is currently on-going. The outcome of this investigation will be communicated through a follow-up report. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[137129501]
A customer reported multiple p07p error codes, generated when testing cobas hpv for use on the cobas 6800/8800 system on their cobas 6800 system (serial id (b)(4)). Error code p07p is indicative of a volume error during supernatant removal. A local field service engineer went onsite and performed the processing head tightness check on the customer's cobas 6800 system, which failed at several positions. Additionally, there was evidence of leakage in specific areas of the cobas 6800 system. No erroneous results were alleged, and no harm or injury was indicated through the case. When error codes are generated for the kit controls or donor/patient samples, the test run/samples are invalidated and need to be repeat tested per the instructions for use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2019-00007 |
| MDR Report Key | 8355617 |
| Date Received | 2019-02-20 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-02-01 |
| Date Mfgr Received | 2019-02-05 |
| Date Added to Maude | 2019-02-20 |
| 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 | 2019-02-20 |
| Model Number | NA |
| Catalog Number | 5524245001 |
| 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 S NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-20 |