MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW STREP A 2; MOLECULAR IVD FOR ID NOW STREP A 2

Catalog Number	734-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Incoming inspection records were reviewed for the swab provided in the id now strep a 2 kit, which is manufactured by (b)(4).Inspection is designed to test the durability of the swab under normal use conditions in a health care facility.All inspection specifications for the sterile foam swab pn 25-1506 1pf, lot number # 5802 were met.The current incident rate for damaged/breaking swabs for lot 5802 based on the total lot count is (b)(4).(b)(4) (manufacturer) reported that they inspected their retention samples, and all were found as expected with no visible or detectable flaw in the applicator stick that could cause premature breakage.The batch record was reviewed and all quality checks performed passed inspection.There were no non-conformance raised during the manufacture of lot # 5802.
Event or Problem Description
A customer reported the sterile throat swab provided in the id now strep a 2 kit breaking in a pediatric male patient's mouth.The customer stated that the patient bit down during the sample collection and the plastic shaft of the swab broke.The broken plastic swab shaft went down the patient's throat and was then expelled when the patient vomited.The customer stated the patient was not injured and did not require treatment.The customer did not report any problems with the id now strep a 2 assay; the complaint is exclusively concerning the sterile collection swab provided in the assay kit.The sterile collection swabs provided in the id now strep a 2 kit are manufactured by (b)(4) and received at abbott diagnostics (b)(4) where they are inspected and then added to the assay kits.(b)(4) (manufacturer) was notified by abbott diagnostics (b)(4) of the complaint.

• Brand Name: ID NOW STREP A 2
• Common Device Name: MOLECULAR IVD FOR ID NOW STREP A 2
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• MDR Report Key: 9470625
• Report Number: 1221359-2019-00086
• Device Sequence Number: 19566836
• Product Code: PGX
• UDI-Device Identifier: 10811877010552
• UDI-Public: 011081187701055210M109670
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/12/2019

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 Catalogue Number: 734-000
• Device Lot Number: M109670
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1