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	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The fill 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 igg reagent was not returned for evaluation.No hardware errors or other assay issues were reported in conjunction with this event.The field service engineer (fse) did not find any instrument issue which may have contributed to this event.No manufacturer guarantees both a specificity and sensitivity of 100%.Differences in each individual assay are expected.In conclusion the cause of the discordant results could not 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) 2021 the customer reported one erroneously negative sars-cov-2 igg (access sars-cov-2 igg assay, part number c58961, lot number 971261) result was generated for one patient on the customer's unicel dxi 800 access immunoassay analyzer (part number 973100 and serial number (b)(4)).On (b)(6) 2021, one non-reactive access sars-cov-2 igg result of 0,33 s/co was obtained and questioned by customer as the patient was vaccinated.Per customer the patient had received the second dose of vaccine fourteen (14) days before the access result (vaccine name not provided).Then the customer repeated the sample patient on an alternate methodology (name not provided) with a discordant result.No further information was provided.No affect to patients or end-users has been reported in connection with this event.No hardware errors or issues with other assays were reported in conjunction with this event.Calibration passed on 18feb2021 using reagent lot 971261 and calibrator lot 988702.Quality control (qc) was passing within the laboratory¿s established ranges.A field service engineer (fse) was dispatched on (b)(6) 2021.The fse did not find any instrument issue which may have contributed to this event.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: 11567834
• Report Number: 9680746-2021-00026
• Device Sequence Number: 4352510
• 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): 03/25/2021

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?: Yes
• Distributor Facility Aware Date: 03/11/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1