MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-02 for DISCOVERY DXA manufactured by Hologic, Inc..
[69204685]
Patient Sequence No: 1, Text Type: N, H10
[69204686]
After review of reports, the bone density center staff realized that the incorrect reference databases were utilized for the calculation of t-scores for a subset of black and/or hispanic study subjects in the past year. It has been our longstanding policy to use ethnicity- and gender-matched reference databases for t-score calculation; however, bone density scans that were obtained on 1 of our 3 dxa machines (scanner qd3) mistakenly had all scans compared to a white gender-matched reference database, irrespective of reported ethnicity. This database problem led to mis-reported t-scores for a total of about 230 patients, including about 100 black patients (at both hip and spine) and about 130 hispanic patients (for hip only). This inadvertent error was caused when a hologic technician input the incorrect reference number into one of the dxa machine during routine maintenance of the scanner. Hologic is an outside vendor and manufacturer of the bone density machines. Manufacturer response for hologic dxa bone density machine, discovery dxa system (per site reporter): the hologic manufacturer is working with the hospital to correct. The hospital's action plan includes, but is not limited to: we alerted the hospital leadership and safety specialists that problem exists. We have identified all affected patients and their ordering providers. The ordering mds that are disproportionally affected include those specific outpatient and primary care practices. We re-analyzed and amended the affected reports. A workflow is in place for all scans that were created after our new, post-ehr go live date. These reports will be re-analyzed and amended in the next month. To amend patient's medical records, we will be contacting the ordering provider using the electronic medical record to alert providers of the new report, and to explain the rationale for the change. We will also contact the medical directors of clinical areas that were impacted to seek their help in local follow-ups with patients. The company was contacted (hologic dxa manufacturer) to inform them of the inappropriate switching of reference databases by their technician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6372333 |
| MDR Report Key | 6372333 |
| Date Received | 2017-03-02 |
| Date of Report | 2016-09-12 |
| Date of Event | 2016-08-16 |
| Report Date | 2016-09-05 |
| Date Reported to FDA | 2016-09-05 |
| Date Reported to Mfgr | 2016-09-05 |
| Date Added to Maude | 2017-03-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DISCOVERY DXA |
| Generic Name | DENSITOMETER, BONE |
| Product Code | KGI |
| Date Received | 2017-03-02 |
| ID Number | QD3 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC, INC. |
| Manufacturer Address | 250 CAMPUS DRIVE MARLBOROUGH MA 01752 US 01752 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-02 |