MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2011-06-27 for LIGHTCYCLER 480 (96 WELL) 04640268001 manufactured by Roche Diagnostics.
[9238366]
The block cycler was returned for investigation. The thermabase was deformed, all peltiers were working, and all sensors on the block cycle were out out specification and did not generate an error. The pcb was working specified. The issue could not be reproduced during the invesetigation, using the same firmware version, block cyler and pcb for the investigation. The observed smoke was from the melted microwell plate and does not contain harmful substances. The risk of fire inside the instrument is very unlikely as the instrument is ul certified. There have been no similar cases in the last 3 years. To improve the reliability in a malfunction situation, the firmware on the pcb should be upgarded with a watchdog timer. In case of losing the microprocessosr clock the timer would be able to switch off the power to the block cycler. It was determined there was no health hazard to patients or operators. No results were generated.
Patient Sequence No: 1, Text Type: N, H10
[17920239]
It was unknown if the initial reporter sent report to the fda. This event occurred austria.
Patient Sequence No: 1, Text Type: N, H10
[18044326]
The user experienced an issue with the lightcycler 480 instrument. After five cycles, the software "hung up" and the block cycler continued to heat for approximately one hour. The customer realized the issue when he saw smoke at the rear of the instrument and turned it off. The user then noted the multiwell plate was completely melted and fused onto the block cycler. It was also noted the pcb from the block was deformed. No patients were involved in the event and no one was injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1823260-2011-03463 |
| MDR Report Key | 2140866 |
| Report Source | 01,05,06 |
| Date Received | 2011-06-27 |
| Date of Report | 2011-08-04 |
| Date of Event | 2011-06-08 |
| Date Mfgr Received | 2011-06-08 |
| Date Added to Maude | 2011-06-27 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | NA JENNIFER WOLFGRAM |
| Manufacturer Street | 9115 HAGUE ROAD NA |
| Manufacturer City | INDIANAPOLIS IN 46250 |
| Manufacturer Country | US |
| Manufacturer Postal | 46250 |
| Manufacturer Phone | 3175217008 |
| Manufacturer G1 | ROCHE DIAGNOSTICS GMBH |
| Manufacturer Street | NONNENWALD 2 NA |
| Manufacturer City | PENZBERG 68305 |
| Manufacturer Postal Code | 68305 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHTCYCLER 480 (96 WELL) |
| Generic Name | CHEMISTRY/MICRO ANALYZER |
| Product Code | JJF |
| Date Received | 2011-06-27 |
| Model Number | NA |
| Catalog Number | 04640268001 |
| Lot Number | NA |
| ID 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 | 9118 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-27 |