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

Catalog Number	C58957
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Full patient identifier is case-(b)(6).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.Calibration and system verifications met specifications at the time of the event.Although the customer's low quality control was reported to be out, recalibration resolved the issue.There insufficient evidence to reasonably suggest a malfunction.In conclusion, the cause of this event cannot be determined with the available information.
Event or Problem Description
On (b)(6) 2020 the customer reported erroneous non-reactive covid (sars-cov-2 igm assay, part number c58957 and lot number 971230) results for seven patients were generated on the customer's refurbished access2 immunoassay analyzer (part number 386220 and serial number (b)(4)).The customer did not indicate whether the non-reactive covid results were reported out of the laboratory.The customer did not report a change to patient treatment or management for any of the patients in conjunction with the event.There were no hardware errors or other assay issues reported in conjunction with this event.System performance indicators such as system check, calibration and level 2 quality control (qc) were passing within specifications at the time of the event.The customer's level 1 qc was out of specifications high but recovered within specifications when the system was recalibrated.There were no issues with sample integrity reported by the customer.Customer did not provide sample information such as sample tube manufacturer, centrifugation, handling or other sample processing 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: 10786521
• Report Number: 9680746-2020-00045
• Device Sequence Number: 3645373
• Product Code: QKO
• UDI-Device Identifier: 15099590738617
• UDI-Public: (01)15099590738617(17)210213(11)200817(10)971230
• Combination Product (Y/N): N
• 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): 11/04/2020

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 Expiration Date: 02/13/2021
• Device Catalogue Number: C58957
• Device Lot Number: 971230
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1