MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-03-27 for AGILITY 67000 manufactured by Dynex Technologies Inc.
[103940261]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103940262]
Dynex is the provider of a service to assist our customers with writing their assay parameter files for automation of their assays on the dynex analyzers. The end user is then responsible for validation of these files for their intended application. During the process of transferring an assay parameter file for an agility analyzer customer, we noticed an inconsistency between the parameter file and what is described in the assay package insert. When we contacted affected customers, one user informed us that as a consequence of this they had potentially reported incorrect patient results. The affected assay parameter file is quantiferon? Qft tb gold 4 point agility. The assay parameter file includes the s4 (zero standard) in the standard curve & line equation. According to the qft-tb gold elisa assay package insert, the zero standard should not be included in the standard curve. Inclusion of s4 affects the correlation coefficient and line equation causing the curve to deviate (refer to the attached report), with the potential for test values close to the assay cut off for positive/ negative/ indeterminate (0. 35iu/ml) to give discrepant qualitative test results. An additional control is included in the assay whereby the r squared result must be > 0. 9604 (correlation coefficient r>0. 98) for the assay to be valid. From our investigation, the r squared values given on the test reports would mostly be below this limit therefore invalidating the results. Dynex is now working with the four sites that have used the assay to ascertain the full clinical implication. According to the qft-tb gold elisa package insert (03/16), limitations section: "results for qft testing must be used in conjunction with each individual's epidemiological history, current medical status, and results of other diagnostic evaluations". "the predictive value of a positive qft result in diagnosing m. Tuberculosis infection depends on the probability of infections, which is assessed by histological, epidemiological, diagnostic and other findings. A diagnosis of latent tuberculosis infection (ltbi) requires that tuberculosis disease must be excluded by medical evaluation including assessment of current medical and diagnostic disease as indicated. A negative result must be considered with the individual's medical and historical data relevant to probability of m. Tuberculosis infection and potential risk of progression to tuberculosis disease, particularly for individuals with impaired immune function. Negative predictive values are likely to be low for persons suspected to have m. Tuberculosis disease and should not be relied on to exclude disease".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1117676-2018-00001 |
| MDR Report Key | 7372622 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-03-27 |
| Date of Report | 2018-03-03 |
| Date Mfgr Received | 2018-03-03 |
| Date Added to Maude | 2018-03-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS CANDICE PROWSE |
| Manufacturer Street | 14340 SULLYFIELD CIRCLE |
| Manufacturer City | CHANTILLY VA 201511621 |
| Manufacturer Country | US |
| Manufacturer Postal | 201511621 |
| Manufacturer Phone | 7038031218 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AGILITY |
| Generic Name | AUTOMATED ELISA SYSTEM |
| Product Code | MWA |
| Date Received | 2018-03-27 |
| Model Number | AGILITY |
| Catalog Number | 67000 |
| Lot Number | NA |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | DYNEX TECHNOLOGIES INC |
| Manufacturer Address | 14340 SULLYFIELD CIRCLE CHANTILLY VA 201511621 US 201511621 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-27 |