MAUDE Adverse Event Report: CLARE DISCRETE MFG IO ACCESS SARS-COV-2 IGM; IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS

Catalog Number	C58957
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The customer did not supply patient demographics such as age, date of birth, weight, ethnicity or race.The access sars-cov-2 igm reagent was not returned for evaluation.There were no reports of other instrument issues.There were no reports of other issues with this assay.The primary cause of the event could not be determined with the available information.There is no evidence to reasonably suggest an instrument malfunction.Per current cdc (united states centers for disease control and prevention) guidelines available on the cdc website, igm antibody can persist for weeks to months following infection.Persistence of detectable antibodies may vary by the test used.
Event or Problem Description
On (b)(6) 2021 the customer reported persistent elevated sars-cov-2 igm (access sars-cov-2 igm assay, part number c58957, lot number 971256) results were generated on the customer's dxi 800 access immunoassay w/spot b analyzer (part number a71456 and serial number (b)(4)).The physician reported that one patient that persistent elevated sars-cov-2 igm results post covid-19 infection while the patient¿s spouse¿s sars-cov-2 igm results had returned to zero weeks prior.The data supplied by the physician also included sars-cov-2 igg results: (b)(6).No affect to patients or end-users has been reported in connection with this event.Calibration, qc, and system check data was not provided by the customer.The customer did not believe the igm values obtained on the instrument to be incorrect.The inquiry was regarding the normal time of igm reactivity in individuals.There were no reports of other instrument issues.There were no reports of other issues with this assay.Sample collection, handling and processing information such as sample type, sample volume collected, centrifugation, storage and other sample related information was not provided by the customer.

• Brand Name: ACCESS SARS-COV-2 IGM
• Common Device Name: IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS
• Manufacturer (Section D): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills ; EI
• MDR Report Key: 11716383
• Report Number: 9680746-2021-00032
• Device Sequence Number: 3921778
• Product Code: QKO
• UDI-Device Identifier: 15099590738617
• UDI-Public: (01)15099590738617(17)210410(11)201012(10)971256
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/23/2021

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 Expiration Date: 04/10/2021
• Device Catalogue Number: C58957
• Device Lot Number: 971256
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1