MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-02-13 for VANTERA CLINICAL ANALYZER 003-00095 ADH manufactured by Liposcience Inc.
[5510857]
A sequencing error in software code installed on a (b)(4) clinical analyzer resulted in a mismatch between sample id and test results reported. As a result of this software anomaly, incorrect test results were issued for a patient. The software anomaly did not cause an injury to the operator of the instrument. The incorrect test results were sent to a physician who contacted liposcience when the results were inconsistent with the patient's medical history and previous test results. There is no report of injury to the patient as a result of the physician receiving incorrect test results.
Patient Sequence No: 1, Text Type: D, B5
[12813211]
The instrument was not returned to liposcience, however an evaluation was conducted by remote access function of the instrument. The evaluation that was conducted in provided is attached.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007701857-2015-00001 |
| MDR Report Key | 4535826 |
| Report Source | 07 |
| Date Received | 2015-02-13 |
| Date of Report | 2015-01-15 |
| Date of Event | 2015-01-15 |
| Date Mfgr Received | 2015-01-15 |
| Device Manufacturer Date | 2012-05-01 |
| Date Added to Maude | 2015-03-19 |
| 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 | SUZETTE WARNER |
| Manufacturer Street | 2500 SUMNER BLVD |
| Manufacturer City | RALEIGH NC 276160000 |
| Manufacturer Country | US |
| Manufacturer Postal | 276160000 |
| Manufacturer Phone | 9192561326 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VANTERA CLINICAL ANALYZER |
| Generic Name | VANTERA |
| Product Code | NSU |
| Date Received | 2015-02-13 |
| Model Number | 003-00095 ADH |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIPOSCIENCE INC |
| Manufacturer Address | RALEIGH NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-13 |