MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. CLEARVIEW PBP2A SA CULTURE COLONY TEST; SYSTEM, TEST, GENOTYPIC DETECTION, RESISTANT MARKERS, STAPHYLOCOCCUS COLONIES

Catalog Number	893-000
Medical Device Problem Codes	Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : single-use, device discarded.
Event or Problem Description
The customer reported two (2) reagent and sample exposure to the skin with the clearview pbp2a sa culture colony test performed on (b)(6) 2023.This mfr.Report addresses event one (1) of two (2).Per the customer, the tube holding the reagent and sample "self-ejected" from the support tray, which caused the sample and reagent of the clearview pbp2a sa culture colony test to splash onto the countertop and onto the intact skin of the lab technician.The tray was on a flat sterile surface.The customer stated an allergic test was not initiated.The customer confirmed there was no patient harm due to the exposure.Additionally, the customer confirmed there was no delay or impact in their treatment.
Event or Problem Description
The customer reported two (2) reagent and sample exposure to the skin with the clearview pbp2a sa culture colony test performed on (b)(6) 2023.This mfr.Report addresses event one (1) of two (2).Per the customer, the tube holding the reagent and sample "self-ejected" from the support tray, which caused the sample and reagent of the clearview pbp2a sa culture colony test to splash onto the countertop and onto the intact skin of the lab technician.The tray was on a flat sterile surface.The customer stated an allergic test was not initiated.The customer confirmed there was no patient harm due to the exposure.Additionally, the customer confirmed there was no delay or impact in their treatment.
Additional Manufacturer Narrative
Udi: (b)(4).The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H6:medical device problem code , d4 - unique identifier (udi) # h3 other text : single-use, device discarded.
Event or Problem Description
The customer reported two (2) reagent and sample exposure to the skin with the clearview pbp2a sa culture colony test performed on (b)(6) 2023.This mfr.Report addresses event one (1) of two (2).Per the customer, the tube holding the reagent and sample "self-ejected" from the support tray, which caused the sample and reagent of the clearview pbp2a sa culture colony test to splash onto the countertop and onto the intact skin of the lab technician.The tray was on a flat sterile surface.The customer stated an allergic test was not initiated.The customer confirmed there was no patient harm due to the exposure.Additionally, the customer confirmed there was no delay or impact in their treatment.
Additional Manufacturer Narrative
Testing was performed at abbott diagnostics scarborough, inc.On retained kit lot 234603w with internal positive quality control samples and negative quality control swabs.All test results were valid and performed as expected.Additionally, the manufacturing records and quality control release testing was reviewed for test kit part number 893-000 / lot 234603w.The lot met the required release specifications.A review of the complaints reported as structural issues (packaging) (confirmed and unconfirmed, conflicting results) related to kit lot 234603w showed that the complaint rate is (b)(4).Abbott diagnostics scarborough was unable to determine the exact root cause of the reported issue.H3 other text : single-use, device discarded.

• Brand Name: CLEARVIEW PBP2A SA CULTURE COLONY TEST
• Common Device Name: SYSTEM, TEST, GENOTYPIC DETECTION, RESISTANT MARKERS, STAPHYLOCOCCUS COLONIES
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.; 10 southgate road; scarborough ME 04074
• Manufacturer Contact: rachel blackwell ; 10 southgate road; scarborough, ME 04074 ; 6613888803
• MDR Report Key: 17565993
• Report Number: 1221359-2023-01334
• Device Sequence Number: 15167197
• Product Code: MYI
• UDI-Device Identifier: 10811877011238
• UDI-Public: 10811877011238
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2023

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: Health Professional
• Device Expiration Date: 06/28/2024
• Device Catalogue Number: 893-000
• Device Lot Number: 234603W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2023
• Supplement Date Received by Manufacturer: 08/31/2023; 10/06/2023
• Initial Report FDA Received Date: 08/17/2023
• Supplement Report FDA Received Date: 09/05/2023; 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic