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

Model Number	55161
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
Investigation of this event is in progress.A follow-up report will be submitted upon completion of the investigation.
Additional 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
• Common Device Name: 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
• Report Number: 2032598-2023-00001
• Device Sequence Number: 20964329
• Product Code: JJQ
• UDI-Device Identifier: 00816565021530
• UDI-Public: 816565021530
• Combination Product (Y/N): N
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 11/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown