MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-05 for COBAS 8800 SYSTEM 05412722001 manufactured by Roche Molecular Systems, Inc..
[137023912]
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
[137023913]
A customer from the usa alleged result discrepancies for one patient when tested with the cobas (b)(6) test. No harm or injury was alleged or occurred. While the investigation was on-going, in (b)(4) 2019, a roche field service engineer went to the customer site and performed the processing head tightness check that resulted in a few positions failing the check on both of the customer's cobas 8800 systems (serial ids (b)(4)). The field service engineer also indicated that droplets were observed on the instrument decks. The relationship of the failed processing head tightness check to the alleged discrepant result is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243471-2019-00005 |
| MDR Report Key | 8304775 |
| Date Received | 2019-02-05 |
| Date of Report | 2019-03-13 |
| Date of Event | 2018-12-14 |
| Date Mfgr Received | 2019-01-11 |
| Date Added to Maude | 2019-02-05 |
| 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 8800 SYSTEM |
| Generic Name | AUTOMATED BLOODBORNE PATHOGEN TEST EQUIPMENT |
| Product Code | MZA |
| Date Received | 2019-02-05 |
| Model Number | NA |
| Catalog Number | 05412722001 |
| 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 SOUTH NA BRANCHBURG NJ 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-05 |