MAUDE Adverse Event Report: MEDIVATORS RAPICIDE PA HIGH-LEVEL DISINFECTANT TEST STRIPS; CHEMICAL INDICATOR

Model Number	ML02-0118
Medical Device Problem Codes	Shelf Life Exceeded (1567); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medivators field service engineer reported, while on site servicing the facility's advantage plus automated endoscope reprocessor, the facility had been using expired test strips to check the minimum required concentration (mrc) of rapicide pa high level disinfectant used in the aer.There is potential that hld used with their aer was not properly verified for mrc, thus there is potential that endoscopes were not adequately high-level disinfected.Medivators fse informed the operators and team leader that the test strips were expired and the facility were going to order new test strips immediately.Rapicide pa test strips instructions for use warns users to not use the strips after the expiration date.There have been no reports of patient harm.This complaint will continue being monitored in medivators complaint handling system.(b)(4).
Event or Problem Description
Medivators field service engineer reported, while on site servicing the facility's advantage plus automated endoscope reprocessor, the facility had been using expired test strips to check the minimum required concentration (mrc) of rapicide pa high level disinfectant used in the aer.There is potential that hld used with their aer was not properly verified for mrc, thus there is potential that endoscopes were not adequately high-level disinfected.

• Brand Name: RAPICIDE PA HIGH-LEVEL DISINFECTANT TEST STRIPS
• Common Device Name: CHEMICAL INDICATOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 7498577
• Report Number: 2150060-2018-00037
• Device Sequence Number: 2222521
• Product Code: JOJ
• UDI-Device Identifier: 00677964064074
• UDI-Public: 00677964064074
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K152394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: ML02-0118
• Device Lot Number: OK157067
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other