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

Catalog Number	C58957
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2020 the customer reported questioned positive covid igm results (access sars-cov-2 igm, part number c58957 and lot number 971257) were generated on the customer's access 2 (access 2 immunoassay analyzer, part number 8386220 and serial number (b)(4)) for three patients.The customer did not indicate whether the results were released from the laboratory.The customer did not report a change to patient care of treatment in connection with this event.The patient samples were tested at two other sites; one patient tests repeated positive at both sites and two patients' samples tested negative at both site.See following section for details on testing.No hardware errors or issues with other assays were reported in conjunction with this event.System performance indicators such as calibration and quality control were passing within specifications at the time of the event.No issues with sample integrity were reported by the customer.Sample collection, handling and processing information such as sample type, sample volume collected, sample quality, centrifugation time and speed, storage temperature and other information was not provided by the customer.
Additional Manufacturer Narrative
(b)(6).The customer did not provide patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access sars-cov-2 igm assay was not returned for evaluation.There were no reports of system issues at the time of the event.All assay and system verifications met specifications at the time of the event.No hardware errors or flags were reported in conjunction with the event.In conclusion, the cause of this event cannot be determined with the available information.

• Brand Name: ACCESS SARS-COV-2 IGM ASSAY
• 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: 11178228
• Report Number: 9680746-2021-00007
• Device Sequence Number: 14170673
• Product Code: QKO
• UDI-Device Identifier: 15099590738617
• UDI-Public: (01)15099590738617(17)210315(11)200916(10)971246
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 01/15/2021

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: 03/15/2021
• Device Catalogue Number: C58957
• Device Lot Number: 971246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1