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

Model Number SARS-COV-2 IGG REAGENT

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

Full patient identifier is (b)(6).The customer did not provide patient demographics such as age, date of birth, 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.Review of customer supplied data showed that the reagent pack used in the calibration of the access immunoassay analyzer serial number (b)(4) had the "pex" flag which indicates that the "open pack stability time has elapsed for the reagent pack.The system measures this time from the time it first punctures the pack." customer was not running quality control samples.No hardware errors or other assay issues were reported in conjunction with this event.In conclusion, the cause of this event cannot be determined with the available information.

Event Description

On (b)(6) 2020, the customer reported non-reproducible erroneously elevated sars-cov-2 igg (access sars-cov-2 igg assay, part number c58961 and lot number 971196) patient results were generated on the customer's access 2 immunoassay analyzer (part number 81600n and serial number (b)(4)).The sars-cov-2 igg test was repeated with the same samples on a different access 2 immunoassay analyzer (part number 81600n and serial number (b)(4)) ,and lower results were obtained.The results from the instrument serial number (b)(4) were reported out of the laboratory.There was no report of change to patient treatment or management reported in association with this event.No hardware errors or other assays issues reported in conjunction with this event.Calibration performed on 13sep2020 passed.It was noted that the calibration showed "pex" flags indicating the open pack stability time had elapsed for the reagent pack.Other system performance indicators such as system check were not provided for review; customer was not running quality control samples and therefore no quality control results were provided for review.Sample collection and processing information such as sample type, volume collected, storage and handling conditions such as temperature and centrifugation time and speed, or other sample processing information was not provided.

• Brand Name: SARS-COV-2 IGG REAGENT
• 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 55318 ; 9533681224
• MDR Report Key: 10643056
• MDR Text Key: 210265650
• Report Number: 9680746-2020-00039
• Device Sequence Number: 1
• Product Code: QKO
• UDI-Device Identifier: 15099590738648
• UDI-Public: (01)15099590738648(17)210114(11)200519(10)971196
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Model Number: SARS-COV-2 IGG REAGENT
• Device Catalogue Number: C58961
• Device Lot Number: 971196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2020
• 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