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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW COVID-19 2.0 TEST KIT 24T JAPAN; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

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ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ID NOW COVID-19 2.0 TEST KIT 24T JAPAN; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID Back to Search Results
Catalog Number 192-000J
Device Problems Break (1069); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/14/2023
Event Type  malfunction  
Event Description
The customer reported that during use of the id now covid-19 2.0 assay on a child, the head of the nasal pharyngeal swab dislodged and was left in the nasal pharyngeal cavity of the patient.The doctor removed the swab head with tweezers.The customer confirmed there was no harm to the patient.
 
Manufacturer Narrative
This report is being filed on an international product, list number 192-000j that has a similar product distributed in the us, list number 192-000.The investigation remains in progress.A supplemental report will be provided after completion or upon receipt of new information.Single use; device discarded.
 
Event Description
The customer reported that during use of the id now covid-19 2.0 assay on a child, the head of the nasal pharyngeal swab dislodged and was left in the nasal pharyngeal cavity of the patient.The doctor removed the swab head with tweezers.The customer confirmed there was no harm to the patient.
 
Manufacturer Narrative
D4, g4: this report is being filed on an international product, list number 192-000j that has a similar product distributed in the us, list number 192-000.Investigation conclusion: inspections were performed at abbott diagnostics scarborough, inc.During routine complaint testing on retained kit lot m217624.No damage or defects were observed on the patient swab lots p0848/p0847/s0658 and part number pk002546/pk002546/pk002197.The customer's complaint was not replicated.Additionally, the manufacturing records and quality control release documentation were reviewed for kit blank swab part number pk002546, pk002546, pk002197 / kit swab lot number p0848, p0847, s0658; the accessory met all release criteria.A review of the complaints reported as broken swab during nasopharyngeal use for lot m217624 based on the total quantity of kits distributed is 0.00543%.The reported issue is anticipated in nature and severity for id now covid-19 according to risk documentation.Abbott diagnostics scarborough, inc.Was unable to determine the exact root cause of the reported issue.H6 - medical device problem code h3 other text : single use; device discarded.
 
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Brand Name
ID NOW COVID-19 2.0 TEST KIT 24T JAPAN
Type of Device
REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
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 Key16432650
MDR Text Key310259107
Report Number1221359-2023-00390
Device Sequence Number1
Product Code QJR
Combination Product (y/n)N
Reporter Country CodeJP
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/10/2023
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
Device Operator Health Professional
Device Expiration Date10/15/2023
Device Catalogue Number192-000J
Device Lot NumberM217624
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/14/2023
Initial Date FDA Received02/23/2023
Supplement Dates Manufacturer Received05/09/2023
Supplement Dates FDA Received05/10/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/17/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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