MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-09-12 for LIASON TREPONEMA ASSAY 310480 manufactured by Diasorin S.p.a..
[3744713]
Diasorin inc. Received a customer complaint by phone on (b)(6) 2013 alleging they had reported four false positive treponema patient results via their lis (laboratory information system). The customer alleges a physician connected to the lis informed a patient (id # (b)(6)) of the initial positive treponema results before confirmatory testing was conducted and then informed the patient of the subsequent negative result.
Patient Sequence No: 1, Text Type: D, B5
[11167831]
Diasorin inc. Received a customer complaint by phone on (b)(6) 2013 alleging they had reported four false positive treponema patient results via their lis (laboratory information system). The customer observed a set of unexpected positive treponema results while running the diasorin liaison treponema assay on the liaison analyzer. The samples were tested again the same day in the liaison treponema assay and were negative. Four results (id #'s: (b)(6)) were released to the lis system before the customer noticed the unusual number of positive results and stopped the routine. The customer shut down and restarted the liaison analyzer, repeated the entire run and all samples were negative. The customer alleges a physician connected to the lis informed a patient (id# (b)(6)) of the initial positive treponema results before confirmatory testing was conducted and then informed the patient of the subsequent negative result. According to the guideline cdc mmwr reverse sequence syphilis, initial reactive samples by an eia/cia method should be retested with a quantitative non-treponemal test (rpr/vdrl) and in case of discordant a retest with a treponemal method (tp-pa) as confirmatory test before reporting to patients. Diasorin conducted an analysis of the customer's liaison analyzer log files which revealed that during the initial liaison treponema assay run on (b)(6), 2013 the liaison analyzer reported an error prior to the false positive patient samples being processed. The message "catastrophic error" is documented to the liaison user manual for sw 2. 30, chapter 19 "system warnings and messages". Catastrophic error, require the user to restart the analyzer and the computer (the complete system) since the instrument has exceeded the cycle time and may not be able to perform correctly the remaining jobs. The liaison analyzer log files revealed that the customer did not heed the error message and continued to run patient samples without shutting down and restarting the instrument. The error message occurred at 10:01:22 and the instrument was shut down at 10:59:17. The false positive treponema test results were pipetted and measured between 10:01:22 and 10:59:17. In conclusion diasorin's investigation determined the root cause of the false positive treponema results to be user error as the customer did not follow the instructions provided. The performance of the liaison treponema assay is not in question.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182595-2013-00002 |
| MDR Report Key | 3366581 |
| Report Source | 06 |
| Date Received | 2013-09-12 |
| Date of Report | 2013-09-12 |
| Date of Event | 2013-08-16 |
| Date Facility Aware | 2013-08-16 |
| Report Date | 2013-09-12 |
| Date Reported to FDA | 2013-09-12 |
| Date Reported to Mfgr | 2013-09-12 |
| Date Mfgr Received | 2013-08-16 |
| Device Manufacturer Date | 2013-03-07 |
| Date Added to Maude | 2013-09-26 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | VIA CRESCENTINO, SNC |
| Manufacturer City | SALUGGIA (VC) 13040 |
| Manufacturer Country | IT |
| Manufacturer Postal | 13040 |
| Manufacturer Phone | 161487849 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIASON TREPONEMA ASSAY |
| Product Code | LIP |
| Date Received | 2013-09-12 |
| Catalog Number | 310480 |
| Lot Number | 113028X |
| Device Expiration Date | 2014-01-07 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIASORIN S.P.A. |
| Manufacturer Address | SALUGGIA IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-09-12 |