MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2012-10-24 for PRINTER, THERMAL, 110V 11-781 manufactured by Alere San Diego, Inc..
[15152964]
Caller reported ldx printer is burning labels. There is a burning odor and the labels are brown. The printer is hot to the touch. No injuries were reported.
Patient Sequence No: 1, Text Type: D, B5
[15293697]
Investigation was performed on returned printer and power supply. Conclusion: customer's complaint was not replicated. No burning, no charring and no discoloration was observed on any component. Printer and power supply that was tested did not feel hot to the touch during or after investigation, and no smoking was observed. Contamination was found on roller, causing it not to move properly. Roller and printer worked properly after some of the contamination on roller was removed. No burning marks observed between roller and heater plate. Some faint printing was observed on the left side of the labels, which may have been caused by contamination on roller. No burning marks or brown marks observed on the labels printed during investigation. Issue with the contamination observed on roller cannot be ruled out as the cause of the customer's observations. Contamination may cause the roller and labels that are being fed through to get stuck and cause the printer to print more info on the part of the label stuck between the roller and heater. No corrective action required at this time as no product deficiency was established.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2012-01557 |
| MDR Report Key | 2824201 |
| Report Source | 00,05 |
| Date Received | 2012-10-24 |
| Date of Report | 2012-10-24 |
| Date of Event | 2012-10-10 |
| Date Mfgr Received | 2012-10-10 |
| Date Added to Maude | 2013-02-04 |
| 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 | 0 |
| Manufacturer Contact | CARMEN BERGELIN, MANAGER |
| Manufacturer Street | 9975 SUMMERS RIDGE RD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8588052256 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NI |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRINTER, THERMAL, 110V |
| Generic Name | CHOLESTEROL METER |
| Product Code | CHH |
| Date Received | 2012-10-24 |
| Returned To Mfg | 2012-10-15 |
| Model Number | 11-781 |
| Lot Number | NG |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SAN DIEGO, INC. |
| Manufacturer Address | SAN DIEGO CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-24 |