MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS CIDEX® OPA TEST STRIPS; BIOCIDES TEST STRIPS

Catalog Number	20392
Medical Device Problem Codes	Expiration Date Error (2528); Device Handling Problem (3265)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Asp complaint ref #: (b)(4).
Event or Problem Description
A customer reported using expired cidex® opa test strips to test their cidex® opa solution and the instruments that were cleaned in the tested cidex® opa solution were released and used on patients.They stated they used the test strips because the instructions for use (ifu) states the strips can be used for 90-days after opening the bottle, and the cidex® opa strips came out positive (or purple) indicating the cidex® opa solution meets the minimum effective concentration (mec).There was no report of infection, injury or harm to patient(s) associated with this issue.The customer was advised to discard any remaining cidex® opa test strips and to follow the instructions for use (ifu) which states the unused cidex® opa test strips should be discarded after the expiration date on the outside of the bottle even if it has not reached the 90-day open date.As a matter of policy, advanced sterilization products (asp) has decided to report cases where a customer uses expired product and releases it for use on patients since they cannot guarantee high-level disinfection has been achieved.
Additional Manufacturer Narrative
Asp investigation summary: the investigation included a review of the batch history record, complaint trending by lot number, and system risk analysis (sra).The batch history record was reviewed and test specifications for product release were met.No issues were observed that would contribute to the complaint.Complaint trending by lot number was reviewed for the prior six months from open date and no significant trend was observed.The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low." functional analysis was not performed.The customer disposed of the expired test strips and stated they will not use any test strips beyond the expiration date on the outside of the bottle.The likely assignable cause of this issue is due to user error and failure to follow the instructions for use.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: CIDEX® OPA TEST STRIPS
• Common Device Name: BIOCIDES TEST STRIPS
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 8078374
• Report Number: 2084725-2018-00763
• Device Sequence Number: 1692235
• Product Code: JOJ
• UDI-Device Identifier: 20705037045553
• UDI-Public: 20705037045553
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K991709
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2018

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 Expiration Date: 08/28/2018
• Device Catalogue Number: 20392
• Device Lot Number: 031779
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2018
• Supplement Date Received by Manufacturer: 01/21/2019
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CIDEX® OPA SOLUTION