MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-11-23 for LIAISON 11750 * manufactured by Diasorin Inc ..
[3172899]
The lab device tests for syphilis. Forty nine patients tested "false" positive for the disease which was reported to providers as positive until the malfunction was discovered. What was the original intended procedure? Syphilis testing. Device #1:is this a laboratory device or laboratory test? Yes. Which of the following problems did you observe:questionable patient results. Please describe any follow up actions:repeated assay, results ok, reported out. Manufacturer notified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2988027 |
| MDR Report Key | 2988027 |
| Date Received | 2012-11-23 |
| Date of Report | 2012-11-23 |
| Date of Event | 2012-10-24 |
| Report Date | 2012-11-23 |
| Date Reported to FDA | 2012-11-23 |
| Date Reported to Mfgr | 2013-03-04 |
| Date Added to Maude | 2013-03-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIAISON 11750 |
| Generic Name | LAB INSTRUMENT |
| Product Code | LIP |
| Date Received | 2012-11-23 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | DIASORIN INC . |
| Manufacturer Address | 1951 NORTHWESTERN AVENUE STILLWATER MN 55082028 US 55082 0285 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-23 |