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	06/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A facility reported using expired rapicide pa high level disinfectant test strips for checking the minimum required concentration (mrc) of rapicide pa hld used in their automated endoscope reprocessor.Hld used with their aer was not properly verified for mrc, thus there is potential that endoscopes were not adequately high-level disinfected.The physician who contacted medivators wanted to assess the potential infectious risk to patients that had procedures with endoscopes reprocessed while using the expired test strips.He reported the test strips expired september 2017 and were used as late as early (b)(6) 2018.He also reported the technicians failed to write the date the test strip vial was opened (as indicated on the vial label) to ensure use did not exceed the 4-month open bottle shelf life.Rapicide pa test strips instructions for use warns users to not use the test strips after the expiration date (opened or unopened).The facility reported they reviewed all patient cases from procedures during the time period that expired test strips were used and no infections were noted or patient harm reported.The facility also confirmed they were properly changing the hld solution within 21 days and within the specified shelf life per the rapicide pa hld labeling.This complaint will continue being monitored in medivators complaint handling system.
Event or Problem Description
A facility reported using expired rapicide pa high level disinfectant test strips for checking the minimum required concentration (mrc) of rapicide pa hld used in their automated endoscope reprocessor.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: 7639885
• Report Number: 2150060-2018-00044
• Device Sequence Number: 16573883
• Product Code: JOJ
• UDI-Device Identifier: 00677964064074
• UDI-Public: 00677964064074
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,health
• Initial Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 06/26/2018

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: Other
• Device Expiration Date: 09/30/2017
• Device Model Number: ML02-0118
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 06/26/2018
• 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