MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-12-02 for COBAS P 612 PRE-ANALYTICAL SYSTEM P612 manufactured by Roche Diagnostics.
[169837879]
This event occurred in (b)(6). The investigation is ongoing.
Patient Sequence No: 1, Text Type: N, H10
[169837880]
The initial reporter complained that a user was injured while attempting to troubleshoot an issue with the cobas p 612 pre-analytical instrument. The instrument produced a re-capper error; the sample tube was tilted and stuck in the re-capper module. Operator 1 opened the rear cover of the re-capping module to troubleshoot the issue. Operator 1 noticed a foil on the slot and attempted to remove it. While operator 1 was removing the foil, operator 2 started the instrument causing operator 1 to jam his hand and burn his finger on the heating block. The reporter stated operator 1 was "injured" and was "cut quite severely" on his right-hand wrist and his index and middle finger were burned. Operator 1 started taking antiretroviral medication immediately following the event and is currently still taking. Operator 1 is not having any complications from the event. Operator 1 did not receive any other treatment. The two fingers and wrist of operator 1 have healed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2019-90279 |
| MDR Report Key | 9396065 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-12-02 |
| Date of Report | 2020-03-16 |
| Date of Event | 2019-10-28 |
| Date Mfgr Received | 2019-11-02 |
| Date Added to Maude | 2019-12-02 |
| 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 | MICHAEL LESLIE |
| Manufacturer Street | 9115 HAGUE ROAD |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | SANDHOFERSTRASSE 116 |
| Manufacturer City | MANNHEIM (BADEN-WURTTEMBERG), 68305 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COBAS P 612 PRE-ANALYTICAL SYSTEM |
| Generic Name | AUTOMATED PREANALYTICAL SYSTEM |
| Product Code | JQP |
| Date Received | 2019-12-02 |
| Model Number | P612 |
| Catalog Number | ASKU |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHE DIAGNOSTICS |
| Manufacturer Address | 9115 HAGUE ROAD INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-12-02 |