MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-04-28 for GENEXPERT SOFTWARE INFINITY-48 V4.1A 950-0192 manufactured by Cepheid.
[2126137]
Genexpert infinity xpertise software, version 4. 1a, allows user to enter test orders faster than the request for lab info sys (lis) orders can be processed. In complaint (b)(4), a customer (b)(6) reported visual observation of mismatched pt id and sample results. Upon further investigation, cepheid field support determined that when batch loading cartridges onto the genexpert infinity-48, if input data (patient id, sample id, and cartridge id) are added very quickly, the system may not pair the pt sample with correct lis test order. The incorrect pairing of lis ordered pt id to a sample id can occur if samples are processed faster than lis orders are downloaded. For example, when sample id #1 is scanned, the lis order download starts, but the test can be started before the download has completed. If sample id #2 is scanned before the first lis order download completes, the sample id #2 may be incorrectly paired to the first lis ordered pt id.
Patient Sequence No: 1, Text Type: D, B5
[9254588]
There was no risk of injury to pt during the originating event at (b)(6) (reporting site, (b)(4)) because the site compares all test results to test orders by pt name, sample id test order number and cartridge number. The transposition of data was detected before pt results were reported. The exact configuration that allowed the event to occur was identified (infinity 48 systems with genexpert 4. 1a using host query test order download configuration and batch loading). No other sites used this exact configuration and therefore, could not have experienced the malfunction that may have resulted in a discrepant pt result report. All united states consignees were contacted by phone 04/01/2011. All united states consignees received a copy of email 04/01/2011. All xus customers were notified by 04/08/2011. Each consignee were sent a hard copy corrective action notification by (b)(4) by 04/27/2011. Summary of eval: eval of the (b)(6) discrepant specimen results included: review of customer complaints for similar complaints - none found. Review of unresolved anomaly list for similar issue - none found. Tracing chronological sequence of events of the data hand-off points from lis to infinity for test order downloads, running cartridge, and upload of test results from infinity to lis. Walkthrough of database records and their linkages. Cool walkthroughs for both lis test order download path and path for test result upload to lis. Attempts to reproduce the events by running (b)(6) specific lis configuration using batch loading of cartridges. By evaluating the data hand-off points and seeing how the database records were linking the data within the database, the scenario was able to be reproduced using the specific lis configuration. The combination of using host query lis configuration where the scanning of the sample id requests info from the lis and the rapid loading of cartridges before the lis test order had downloaded were determined to be the root cause. Corrective action has been taken with customers and preventive action will include new software release. No pts were misdiagnosed due to this malfunction. Only one consignee site was configured in such a way as to cause the malfunction. Because infinity results were always compared to lis test results manually, no pt data were affected and the site did not report any discrepant results.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004530258-2011-00001 |
| MDR Report Key | 2160309 |
| Report Source | 07 |
| Date Received | 2011-04-28 |
| Date of Report | 2011-04-27 |
| Date of Event | 2011-03-28 |
| Date Mfgr Received | 2011-03-28 |
| Device Manufacturer Date | 2011-01-28 |
| Date Added to Maude | 2012-03-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JUDITH HOWARD, VP |
| Manufacturer Street | 904 CARIBBEAN DRIVE |
| Manufacturer City | SUNNYVALE CA 94089 |
| Manufacturer Country | US |
| Manufacturer Postal | 94089 |
| Manufacturer Phone | 4084004459 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | 3004530258:4/12/11-001C |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GENEXPERT SOFTWARE |
| Generic Name | GENEXPERT SOFTWARE |
| Product Code | OQW |
| Date Received | 2011-04-28 |
| Model Number | INFINITY-48 V4.1A |
| Catalog Number | 950-0192 |
| Lot Number | 020411A REV C |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CEPHEID |
| Manufacturer Address | 904 CARIBBEAN DRIVE SUNNYVALE CA 94089 US 94089 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-04-28 |