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 Consequences Or Impact To Patient (2199)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient identifier is (b)(6).The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access sars-cov-2 igm reagent was not returned for evaluation.No hardware errors, flags or other assay issues were reported in conjunction with this event.Per the sars-cov-2 igm instructions for use (ifu), part number c65791 c, ¿false positive results for the access sars-cov-2 igm assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes.Due to the risk of false positive results, confirmation of positive results should be considered using a second different assay,¿ and ¿a positive result may not indicate previous sars-cov-2 infection.Consider other information, including clinical history, and local disease prevalence, in assessing the need for an alternative serology test to confirm an immune response.Positive results may be due to past or present infection with non-sars-cov-2 coronavirus strains, such as coronavirus hku1, nl63, oc43, or 229e." although rare, some false positive results may occur.Per the ifu, "the overall negative percent agreement of the access sars-cov-2 igm assay is 99.9% with a 95% confidence interval of 99.5 - 100.0% determined by the wilson score method." in conclusion, the cause of this event cannot be determined with the available information.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.
Event or Problem Description
On (b)(6) 2020, the customer reported one reactive sars-cov-2 igm (access sars-cov-2 igm assay, part number c58957, lot number 971217) result was generated on the customer's access 2 immunoassay analyzer (refurbished) (part number 386220 and serial number (b)(4)).The access result of 1.47 s/co (reportable range: reactive =1.0 s/co) was obtained on (b)(6) 2020.The patient did not present any symptom and had a negative pcr.The sars-cov-2 igg result was also non-reactive (0.02 s/co).The sample for pcr testing was collected the same day as the sample for serology testing.No affect to patients, or end-users has been reported in connection with this event.The customer did not indicate whether the results were reported out of the laboratory.No hardware errors, or issues with other assays were reported in conjunction with this event.Calibration passed on (b)(6) 2020 with reagent lot 971217 and calibrator lot 922425.Quality control (qc) was passing within the laboratory¿s established ranges.System check passed on 5oct2020.There were no issues with sample integrity reported by the customer.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: 10717697
• Report Number: 2122870-2020-00089
• Device Sequence Number: 16973565
• Product Code: QKO
• UDI-Device Identifier: 15099590738617
• UDI-Public: (01)15099590738617(17)210106(11)200710(10)971217
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2021
• Device Catalogue Number: C58957
• Device Lot Number: 971217
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/08/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1