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 11/16/2020

Event Type  malfunction  

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.One patient sample was sent to the marseilles complaint handling unit for investigation.The patient sample was first tested for the sars-cov-2 igg assay.The marseilles chu obtained a reactive result (4.81 s/co).The customer's result was not confirmed.Then, the patient sample was tested with the sars-cov-2 igm assay.The sample was also reactive with the igm assay (32.22 s/co).In conclusion the result obtained by the customer was not reproduced.The patient sample was found reactive for both the access sars-cov-2 igg and access sars-cov-2 igm assays.The cause of this event cannot be determined with the information available.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 a non-reactive sars-cov-2 igg (access sars-cov-2 igg assay, part number c58961, lot number 971197) result was generated on the customer's dxi 800 immunoassay analyzer (part number 973100 and serial number (b)(4)).The patient was coughing and have bilateral pneumonia since (b)(6) 2020.A positive pcr result was obtained on (b)(6) 2020.The patient was hospitalized on (b)(6) 2020, the pcr was positive and a non-reactive diasorin sars-cov-2 igg result was obtained.The pcr was then negative on (b)(6) 2020, but positive again on (b)(6) 2020.At this date, a reactive diasorin sars-cov-2 igg result was obtained.The patient was discharged from the hospital on (b)(6) 2020 after a negative pcr was obtained.The access sars-cov-2 igg result was non-reactive on (b)(6) 2020.Refer to relevant tests section below for more details.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 13nov2020.Quality control (qc) was passing within the laboratory¿s established ranges.System check passed on 9nov2020 and 16nov2020.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: 11020344
• MDR Text Key: 223803518
• Report Number: 9680746-2020-00053
• Device Sequence Number: 1
• Product Code: QKO
• UDI-Device Identifier: 15099590738648
• UDI-Public: (01)15099590738648(17)210123(11)200528(10)971197
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2021
• Device Catalogue Number: C58961
• Device Lot Number: 971197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/24/2020
• Date Manufacturer Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/28/2020
• 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