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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: QUIDEL CORPORATION ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.

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QUIDEL CORPORATION ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. Back to Search Results
Catalog Number 20108
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/03/2020
Event Type  malfunction  
Event Description
Physician office practice noted an unusual increase of rapid strep a tests within one day. Thus, the provider and 6 staff completed rapid strep test a on themselves which resulted in 5 positive and 2 negative. Controls were ran twice during day which were accurate for both positive and negative. Two lots of rapid strep test kits were pulled from shelf. Manufacturer response for rapid strep a test, quick view dipstick strep a test (per site reporter). Message left for customer service and received call from technical support specialist. Case # (b)(4). Action plan included: education of frontline staff for specimen collection, timely use of reagent solution and reading results quindell has offered to process sample if results do not match clinical presentation. Specimen will need to be recollected and sent overnight to qc (quality control) lab. Quindell is completing their own investigation and will follow-up with us after complete.
 
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Type of DeviceANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
Manufacturer (Section D)
QUIDEL CORPORATION
10165 mckellar ct.
san diego CA 92121
MDR Report Key9920710
MDR Text Key186306398
Report Number9920710
Device Sequence Number1
Product Code GTY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/04/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number20108
Device Lot Number705533
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/04/2020
Event Location Other
Date Report to Manufacturer04/03/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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