MAUDE Adverse Event Report: ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ABBOTT ID NOW; REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID

Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Use of abbott id now for covid-19 detection using nasal swabs did not detect any positive results on specimens from six patients who are known covid-19 +.We collected 59 nasal specimens from those coming through our drive thru clinic for np swabs.Nasal specimens were collected before the np swab following the video instructions provided by abbott.Swabs were tested within 2 hours from time of collection, if testing would take longer than 2 hours specimens were placed in the refrigerator and tested within 2-12 hours (abbott claims specimen stability for direct swab collections as follows: 2 hours room temp, 24 hour refrigerated).Np swabs were tested at (b)(6).The below is an outline of the abbott id now nasal specimen results vs.The np results from (b)(6).Of the 59 specimens tested on the id now, 57 resulted as negative and 2 as invalid.We were unable to repeat the 2 invalid results and will not include them in this study to determine performance characteristics.The (b)(6) reported the following, 55 negatives, 2 positives, and 2 inconclusive results.The (b)(6) recommends the following "an inconclusive result is most likely an indication of virus present near the limit of detection and should be treated as a result of detected".For the purposes of this study we will consider these results as positive.Since the id now did not detect any positive specimens i wanted to see if it could detect known positive patients.I was able to obtain nasal specimens (following abbott collection instructions) from 2 patients that tested positive by our in house test a few hours earlier.The additional 2 nasal specimens tested negative for these two patients.We wanted to determine if the id now was capable of detecting covid at all, so we decided to test 4 np specimens that were positive for covid by our in house platform, on the id now (all np specimens collected on (b)(6) and tested by both platforms on (b)(6)).The id now detected 3 of the 4 positives.Of the 4 tested + specimens, 2 of these were the np specimens from the same patients whose nasal specimens were negative, the np swabs were + on the id now.Fda safety report id#: (b)(4).

• Brand Name: ABBOTT ID NOW
• Common Device Name: REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID
• Manufacturer (Section D): ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
• MDR Report Key: 9971632
• Report Number: MW5094166
• Device Sequence Number: 10052228
• Product Code: QJR
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 04/14/2020
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1