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

Catalog Number	C58961
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fill patient identifier is (b)(6).Twenty (20) patients are included in this event.The customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.The access sars-cov-2 igg reagent was not returned for evaluation.No hardware errors or other assay issues were reported in conjunction with this event.The roche assays are ¿total assays¿, detecting igg, igm and iga without distinction.The results of a total assay cannot be compared to the results of an ¿igg-only¿ assay.No manufacturer guarantees both a specificity and sensitivity of 100%.Differences in each individual assay are expected.In conclusion the cause of the non-reactive results could not be determined with the available information.No manufacturer guarantees both a specificity and sensitivity of 100%.Differences in each individual assay are expected.There is no evidence to reasonably suggest an instrument malfunction.
Event or Problem Description
The customer reported discordant non-reactive sars-cov-2 igg (access sars-cov-2 igg assay, part number c58961, lot number 971261) results for twenty patients were generated on the customer's unicel dxi 600 access immunoassay analyzer (part number a30260 and serial number (b)(4)).The customer reported that of 180 samples from patients taking a covid vaccine (name of vaccine and date/time of vaccination were not provided), 20 were negative using the access sars-cov-2 igg assay and reactive using the roche assay.It was not specified if the roche assay targets antibodies anti-nucleocapsid (old one) or antibodies anti-spike protein (new one).No patient data was provided.No affect to patients or end-users has been reported in connection with this event.The customer did not indicate if the result was released outside the laboratory.No hardware errors or issues with other assays were reported in conjunction with this event.Calibration passed on 27feb20212021.Quality control (qc) was passing within the laboratory¿s established ranges.System check passed on 17mar2021.A field service engineer (fse) was dispatched on customer's site on (b)(6) 2021 and could not find any issue with the instrument.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 IGG
• 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: 11595374
• Report Number: 9680746-2021-00030
• Device Sequence Number: 4224412
• Product Code: QKO
• UDI-Device Identifier: 15099590738648
• UDI-Public: (01)15099590738648(17)210612(11)201015(10)971261
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 03/31/2021

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: 06/12/2021
• Device Catalogue Number: C58961
• Device Lot Number: 971261
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 03/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1