MAUDE Adverse Event Report: DGH TECHNOLOGY, INC. SCANMATE A; ULTRASONIC A-SCAN

Model Number	DGH 6000
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of 12/20/2016, the device has been returned to the distributor ((b)(4)).(b)(4) is to coordinate returning the device to dgh.
Event or Problem Description
A user (dr.(b)(6)) alleged experiencing measurement errors when using a dgh 6000 a-scan device.The doctor stated that when performing contact axial length measurements of the eye, (in approximately 2 of every 10 cases) he would have difficulty obtaining measurements.He said in these instances the device would enter estimate mode and measurements taken while in estimate mode differed from axial length measurements achieved with his previous a-scan device.This difference in measurement would result in a refractive calculation error of 2-3 diopters.The doctor claimed that instances of difficulty were typically experienced when attempting to measure eyes with a mature cataracts or posterior sub capsular cataract (psc).He stated that in other cases (when not measuring mature cataracts or posterior sub capsular cataract), the readings are satisfactory and accurate.Measurement information for one patient ((b)(6)) was provided, whose measurements differed by 0.75 mm when compared to the previous device.The doctor has stated that no injuries have occured as a result of the measurement difference.In cases where measurements obtained with the dgh 6000 differed from his previous device, measurements achieved with the previous device were used for refractive calculations.

• Brand Name: SCANMATE A
• Common Device Name: ULTRASONIC A-SCAN
• Manufacturer (Section D): DGH TECHNOLOGY, INC.; 110 summit drive; suite b; exton PA 19341
• MDR Report Key: 6190143
• Report Number: 2522950-2016-00001
• Device Sequence Number: 10953208
• Product Code: ITX
• UDI-Device Identifier: 00857377006094
• UDI-Public: (01)00857377006094
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K093371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 11/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: DGH 6000
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2016
• Initial Report FDA Received Date: 12/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR