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

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.

• Type of Device: ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
• Manufacturer (Section D): QUIDEL CORPORATION; 10165 mckellar ct.; san diego CA 92121
• MDR Report Key: 9920710
• MDR Text Key: 186306398
• Report Number: 9920710
• Device Sequence Number: 1
• Product Code: GTY
• Combination Product (y/n): N
• Number of Events Reported: 1
• 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 Received: 04/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Catalogue Number: 20108
• Device Lot Number: 705533
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/04/2020
• Event Location: Other
• Date Report to Manufacturer: 04/03/2020
• 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