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	05/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021 the customer reported non-reactive sars-cov-2 igg (access sars-cov-2 igg assay, part number c58961, lot number 971198) results for an unknown number of patients were generated on the customer's access 2 immunoassay analyzer (part number 81600n and serial number (b)(4)).The customer reported obtaining positive results in an alternate laboratory (no further information was provided).Additional information regarding the impacted samples was not provided in this event.No affect to patients or end-users has been reported in connection with this event.No error messages or issues with other assays were reported.There were no reports of hardware interventions performed or hardware parts replaced.The expiration date of the reagent lot provided by customer is 23jan2021.Local support discussed differences in methods with the customer.
Additional Manufacturer Narrative
(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 error messages or issues with other assays were reported.There were no reports of hardware interventions performed or hardware parts replaced.Local support and medical scientific affairs discussed differences between assays with the customer as values obtained with different assay methods should not be used interchangeably and differences between methods are expected.In conclusion, an assignable cause of the event cannot be determined with the available information.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.

• 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: 11956468
• Report Number: 9680746-2021-00043
• Device Sequence Number: 17059750
• Product Code: QKO
• UDI-Device Identifier: 15099590738648
• UDI-Public: (01)15099590738648(17)210123(11)200528(10)971198
• 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): 06/08/2021

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: 01/23/2021
• Device Catalogue Number: C58961
• Device Lot Number: 971198
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2021
• Initial Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1