MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-07-22 for LIGHTCYCLER 480 (384 WELL) 04545885001 manufactured by Roche Diagnostics.
[3684110]
The customer alleged they were having repeated issues with the drawer of their lightcycler 480 opening properly. The customer alleged the issue caused a plate to melt. The customer tried re-initializing the instrument, putting in a plate, and starting a run. The customer stated this worked, but the issue happened off and on. The customer stated there were no reports of any injuries due to the melted plate. There were no adverse events. The field service representative determined the lightcycler was misadjusted. He adjusted the loading, x and z. He updated the lamp and door assembly. He performed diagnostic checks for the lamp unit and drawer loading. The unit was operating to specification.
Patient Sequence No: 1, Text Type: D, B5
[10951114]
It was unknown if the initial reporter sent report to the fda. While this device is approved for research use only, it is like or similar to the cobas 4800 system cobas z 480 analyzer which is approved for in vitro diagnostic use.
Patient Sequence No: 1, Text Type: N, H10
[11175568]
A root cause could not be determined. There was no information available for an investigation provided by the customer. It was noted the multiwell plate expired on 10/31/2007.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1823260-2013-04403 |
| MDR Report Key | 3239280 |
| Report Source | 05,06 |
| Date Received | 2013-07-22 |
| Date of Report | 2013-09-09 |
| Date of Event | 2013-07-12 |
| Date Mfgr Received | 2013-07-12 |
| Date Added to Maude | 2013-10-21 |
| 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 82377 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 82377 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIGHTCYCLER 480 (384 WELL) |
| Generic Name | CHEMISTRY/MICRO ANALYZER |
| Product Code | JJF |
| Date Received | 2013-07-22 |
| Model Number | NA |
| Catalog Number | 04545885001 |
| 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 | 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-07-22 |