MAUDE Adverse Event Report: AMEDITECH, INC. EREADER+ DRUG SCREENING INSTRUMENT

Model Number 55161

Device Problem Unintended Electrical Shock (4018)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2023

Event Type  malfunction  

Event Description

It was reported that the ereader+ instrument shocked a clinician when they were adjusting the instrument's connection to the adjacent computer.Reportedly, the shock occurred when touching the usb cord that connected the instrument to the back of the computer.The clinician did not want to troubleshoot the issue further, due to fear of getting shocked again.No injury and/or medical intervention was noted as a result of this event.

Manufacturer Narrative

Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

The instrument was returned for investigation.The unit and its power supply passed electrical safety testing, indicating that no hazardous voltages were present.A review of the incoming inspection record for the returned instrument encountered no issues.A review of the instrument's operator guide found no evidence of user error or misuse.Based on the completed investigation activities and available information, an assignable cause could not be determined.

• Brand Name: EREADER+ DRUG SCREENING INSTRUMENT
• Type of Device: EREADER+
• Manufacturer (Section D): AMEDITECH, INC.; 9940 mesa rim rd; san diego CA 92121
• Manufacturer (Section G): AMEDITECH, INC.; 9940 mesa rim rd; san diego
• Manufacturer Contact: irene yasuda ; 9940 mesa rim rd; san diego, CA 92121 ; 6193726179
• MDR Report Key: 16857807
• MDR Text Key: 314446468
• Report Number: 2032598-2023-00001
• Device Sequence Number: 1
• Product Code: JJQ
• UDI-Device Identifier: 00816565021530
• UDI-Public: 816565021530
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 55161
• Device Catalogue Number: 55161
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other