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

Catalog Number C58961

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

Patient identifier: the fill patient identifier is case-(b)(6).Repeatable non-reactive sars-cov-2 igg results were reported for three patients on (b)(6) 2020.Age or date of birth, sex, weight and ethnicity: the customer did not supply patient demographics such as age, date of birth, sex, weight, ethnicity or race.Device evaluated by mfr: 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.Field service engineer (fse) performed some verification tests.Low volume pipettor matching passed on (b)(6).The instrument is working within specifications.Further comparisons were performed with samples across different methodologies with different results and interpretations.No manufacturer guarantees both a specificity and sensitivity of 100%.Differences in each individual assay are expected.The roche and architect assays detects antibodies directed against the nucleocapsid of the virus while the access and ichroma covid-19 ab assays detect antibodies directed against the spike protein, which are more likely to neutralize the virus.The roche and the ichroma covid-19 ab assays are total assays.They detect igm, igg and iga without distinction; therefore, the results are not comparable.In conclusion, the exact cause of this event cannot be determined with the available information.Differences between methods are expected.There is no evidence to reasonably suggest that a malfunction occurred in conjunction with this event.

Event Description

On (b)(6) 2020 the customer reported repeatable non-reactive sars-cov-2 igg (access sars-cov-2 igg assay, part number c58961, lot number 971195) results were generated on the customer's dxi 800 immunoassay analyzer (part number 973100 and serial number (b)(4).On (b)(6) 2020, repeatable non-reactive access sars-cov-2 igg results were obtained for three patients.The access results were discordant with the roche sars-cov-2 ab, the i-chroma ab boditech med sars-cov-2 igg and the abbott architect sars-cov-2 igg.Positive pcr were provided for the three patients.No affect to patients or end-users has been reported in connection with this event.The customer indicated the results were not released outside the laboratory.No hardware errors or issues with other assays were reported in conjunction with this event.Calibration passed on 6nov2020.Quality control (qc) was passing within the laboratorys established ranges.No system check data was provided.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
• Type of Device: IN VITRO DIAGNOSTIC DEVICES: CORONAVIRUS SEROLOGICAL REAGENTS
• Manufacturer (Section D): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills ; EI
• Manufacturer (Section G): CLARE DISCRETE MFG IO; lismeehan; o'callaghans mills ; EI
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; chaska, MN ; 9523681224
• MDR Report Key: 10992648
• MDR Text Key: 253307195
• Report Number: 9680746-2020-00051
• Device Sequence Number: 1
• Product Code: QKO
• UDI-Device Identifier: 15099590738648
• UDI-Public: (01)15099590738648(17)201224(11)200428(10)971195
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/24/2020
• Device Catalogue Number: C58961
• Device Lot Number: 971195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/13/2020
• Date Manufacturer Received: 11/13/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/28/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1