MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION SARS-COV-2 IGG

Model Number	06R8620
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed a false negative sars-cov-2 igg results generated on the architect i2000sr processing module for a (b)(6) year old male patient.The following data was provided (reference range: less than 1.4 s/c = negative): (b)(6) initial result = 0.66 s/c (negative), repeat = 0.63 s/c (negative), repeat on another collection tube drawn at the same time = 0.61 s/c (negative).On (b)(6) 2020 thermofischer quant pcr test was positive for n1 and n2.No impact to patient management was reported.
Additional Manufacturer Narrative
It was discovered on june 26, 2020 that the initial emdr for this issue was submitted under the correct suspect medical device but incorrect manufacturer name, city and state.Mdr number 1415939-2020-00075 has been submitted for the correct manufacturing site and all further information will be documented under that mdr number.Refer to mdr 1415939-2020-00075.

• Brand Name: SARS-COV-2 IGG
• Common Device Name: COV-2 IGG
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 10152433
• Report Number: 3008344661-2020-00045
• Device Sequence Number: 2164427
• Product Code: QKO
• UDI-Device Identifier: 00380740191832
• UDI-Public: 00380740191832
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2020

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
• Operator of Device: Health Professional
• Device Model Number: 06R8620
• Device Catalogue Number: 06R86-20
• Device Lot Number: 16019M800
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 07/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR