MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-23 for AGILITY 67000 manufactured by Dynex Technologies Inc.
[83668212]
Patient Sequence No: 1, Text Type: N, H10
[83668213]
Dynex technologies provides a support function to assist end users with construction of files for automation of assays on dynex technologies' agility analyzer. The end user then is responsible for validation of these assay files for their intended application. On july 25, 2017 dynex technologies was informed that a customer was seeing atypical results when using the qft-(b)(4) gold 8 point agility (us) v2 assay file. On investigation, dynex has discovered differences in this qft-(b)(4) gold 8 point assay file when compared to the quantiferon? -(b)(4) package insert. These differences had been missed by dynex when verifying that the assay settings matched the package insert and by end users during their validation at point of use. Defect descriptions: defect 1- the minimum optical density value for standard s1 is set as 0. 6 instead of 1. 2. Defect 2- the generation of the standard curve and calculation of the line equation in the assay includes standard s8 (zero standard). The impact of these defects is as follows: defect 1- the minimum od value for standard s1 is set as 0. 6; according to the package insert the value should be 1. 200. This means that assay runs in which the od of standard s1 was less than 1. 2 but above 0. 6 would not have been flagged as failing by the instrument software, which would otherwise have resulted in rejection of the plate run. This would be expected to only occur infrequently. Defect 2- the calculation of the standard curve equation in the assay includes standard s8 (the zero standard); according to the package insert, the zero standard should not be part of the calculation of the equation of the standard curve. Including the value of the zero standard affects the correlation coefficient and the equation of the standard curve. This is shown graphically in the appendix. The difference in the calculation of the standard curve means that in cases of patient results where the calculated concentration is near to the assay cut-off value for positive/ indeterminate/ negative (0. 35iu/ml), there could be a discrepancy in the qualitative test result. This is most likely to result in false negative results (ie (b)(6) infection not likely) being reported for such patients. According to the qft-(b)(4) 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 (b)(6) infection depends on the probability of infections, which is assessed by histological, epidemiological, diagnostic and other findings. A diagnosis of latent (b)(6) infection requires that (b)(6) 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 (b)(6) infection and potential risk of progression to (b)(6) disease, particularly for individuals with impaired immune function. Negative predictive values are likely to be low for persons suspected to have (b)(6) disease and should not be relied on to exclude disease".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1117676-2017-00001 |
| MDR Report Key | 6812703 |
| Date Received | 2017-08-23 |
| Date of Report | 2017-08-21 |
| Date Mfgr Received | 2017-07-25 |
| Device Manufacturer Date | 2015-12-28 |
| Date Added to Maude | 2017-08-23 |
| 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 SULYFIELD CIRCLE |
| Manufacturer City | CHANTILLY VA 201511621 |
| Manufacturer Country | US |
| Manufacturer Postal | 201511621 |
| Manufacturer Phone | 7038031218 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | AGILITY |
| Generic Name | AUTOMATED ELISA SYSTEM |
| Product Code | NJO |
| Date Received | 2017-08-23 |
| Model Number | AGILITY |
| Catalog Number | 67000 |
| Lot Number | N/A |
| 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 | 2017-08-23 |