ABBOTT DIAGNOSTICS SCARBOROUGH, INC. CLEARVIEW PBP2A SA CULTURE COLONY TEST; SYSTEM, TEST, GENOTYPIC DETECTION, RESISTANT MARKERS, STAPHYLOCOCCUS COLONIES
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Catalog Number 893-000 |
Device Problems
Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/26/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The remainder of the investigation remains in progress.A supplemental report will be provided after completion.H3 other text : single-use, device discarded.
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Event Description
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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.
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Event Description
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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.
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Manufacturer Narrative
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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.
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Event Description
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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.
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Manufacturer Narrative
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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.
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