MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-22 for COBAS 6800 SYSTEM 05524245001 manufactured by Roche Molecular Systems, Inc..
[140682053]
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
[140682054]
A customer reported the generation of c02h1 flags and invalid result for samples tested, using cobas hbv and hcv tests, on their cobas 6800 system. The c02h1 flag indicates that the target result could not be calculated, either due to an ic dropout or due to the actual target dropping out. This flag invalidates the samples and they must be repeat tested per the instructions for use. A roche field service engineer visited the customer site and performed the process head tightness check, and some positions of the cobas 6800 system's processing transfer head failed the check. The failed positions may cause the generation of the above referenced error code. Additionally, evidence of leakage was observed on the instrument's process module deck. No erroneous results were alleged, and no harm or injury was indicated through the case. When error codes are generated for samples, the samples must be repeat tested per the instructions for use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2019-00008 |
| MDR Report Key | 8363721 |
| Date Received | 2019-02-22 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-01-31 |
| Date Mfgr Received | 2019-02-19 |
| Date Added to Maude | 2019-02-22 |
| 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 6800 SYSTEM |
| Generic Name | AUTOMATED BLOODBORNE PATHOGEN TEST EQUIPMENT |
| Product Code | MZA |
| Date Received | 2019-02-22 |
| Model Number | NA |
| Catalog Number | 05524245001 |
| 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 202S NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-22 |