MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-05-02 for CHOLESTECH LDX NORTH AMERICA 14-874 manufactured by Alere San Diego, Inc..
[2649747]
Customer reported that ldx analyzer would constantly overheat and be hot to touch. Customer also added that tray door opens when it shouldn't and often gets a mag. Read error/used cassette message. She did not say they were burned or injured in any way by the overheating. Technical services replaced customer's meter.
Patient Sequence No: 1, Text Type: D, B5
[9861741]
Product support investigated returned ldx analyzer for customer's claims of overheating. Six lipid cassettes were run on the returned ldx analyzer and no overheating occurred. Six alt/ast cassettes were also run on the analyzer and no overheating occurred. No temperature out of range messages were obtained and the analyzer never felt warm or hot to the touch during testing. The analyzer's temperature readings were between 26c and 28c during the alt/ast testing. No errors were obtained during testing and the analyzer functioned as expected with no problems found. The customer's complaints of overheating, tray opening when it shouldn't, mag. Read errors and used cassette errors were not replicated. No corrective action required at this time as no product deficiency was established.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2012-00633 |
| MDR Report Key | 2575642 |
| Report Source | 05 |
| Date Received | 2012-05-02 |
| Date of Report | 2012-05-02 |
| Date of Event | 2012-04-05 |
| Date Mfgr Received | 2012-04-05 |
| Date Added to Maude | 2012-06-13 |
| 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 | CHOLESTECH LDX NORTH AMERICA |
| Generic Name | CHOLESTEROL METER |
| Product Code | CHH |
| Date Received | 2012-05-02 |
| Returned To Mfg | 2012-04-16 |
| Model Number | 14-874 |
| Lot Number | NG |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2012-05-02 |