MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-12-20 for CHOLESTECH LDX 14-874 manufactured by Alere San Diego, Inc..
[2499533]
Caller alleged that their ldx meter and printer short-circulated and had a burning smell. Both instruments were plugged into a surge protector. The meter was moved while running a test yesterday; a loud pop was heard then a burning smell was detected from both pieces of equipment. Both the analyzer and printer are no longer turning on. The ldx drawer is not shutting. No other analyzers in lab, including those plugged into the same surge protector experienced electrical problems that day. Customer was sent a new ldx meter.
Patient Sequence No: 1, Text Type: D, B5
[9521277]
Returned unit s/n: (b)(4). Returned power supply. In-house optics check cassette (occ) l/n: 252611. Retain demo cassette l/n: d10 7259. End-user reported failure of returned analyzer to power on following occurrence of a loud popping sound, accompanied by a burning smell. Investigation: returned unit powered on normally when connected to returned power supply. Stop, data, and run buttons functioned normally. Rom pack version 3. 40. Total number of runs = 395. Tray speed and movement was normal. Ran occ on returned unit: 94-91-92-92. Ran demo cassette on returned unit and cassette was identified with no issue. Visual inspection of returned power supply found no damage. Power supply remained cool to touch during testing and no burning smell was noted. Visual inspection of returned meter found no damage or evidence of burning around power supply port, on both interior and exterior of ldx analyzer. No burning smell from returned meter was noted. Returned printer s/n: (b)(4). Retain product support meter s/n: (b)(4). Known working power supplies. Known working data cable. In-house optics check cassette (occ) l/n: 252611. Retain demo cassette l/n: d10 7259. End-user reported failure of returned printer on following loud popping sound, accompanied by a burning smell. Investigation: returned printer powered on normally when connected to a known working power supply. Observed loose power supply port on returned printer. Printer only powered on with wiggling of port. Connected retain meter to returned printer. Ran retain occ on retain meter: 85-93-93-93. Ran retain demo cassette on retain meter. Returned printer received and printed data results as expected. Visual inspection found no burn damage to printer. No burning smell was noted during testing. Conclusion: complaint was not replicated. Returned analyzer and power supply performed as expected for working product. Analyzer ran tests properly while attached to the returned power supply. No apparent damage to ldx or power supply was observed during lab testing; no burning smell or visual characteristics indicated that analyzer had sustained high temp. Customer's complaint was not replicated during returned printer testing. Printer failed to power until power port was wiggled around. Noted no burn damage to returned printer and no burning smell during testing. Observed loose printer power port. This issue will be tracked and trended; corrective action not required at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027969-2011-02582 |
| MDR Report Key | 2390044 |
| Report Source | 05,06 |
| Date Received | 2011-12-20 |
| Date of Report | 2011-12-20 |
| Date of Event | 2011-09-19 |
| Date Mfgr Received | 2011-09-20 |
| Date Added to Maude | 2012-02-28 |
| 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, MGR. |
| 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 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CHOLESTECH LDX |
| Generic Name | CHOLESTEROL METER |
| Product Code | CHH |
| Date Received | 2011-12-20 |
| Returned To Mfg | 2011-10-04 |
| Model Number | 14-874 |
| Lot Number | NA |
| ID Number | 14-973 (PRINTER) |
| 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 | 2011-12-20 |