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

Catalog Number C58961

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

Full patient identifier is (b)(6).The customer did not provide patient demographics such as age, date of birth, 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 customer provided a sample to the beckman coulter complaint handling unit (chu) for investigative testing.The chu performed testing on the patient sample using the beckman coulter sars-cov-2 igg assay and the beckman coulter sars-cov-2 igm assay; non-reactive results were obtained for both assays.There is no evidence to reasonably suggest that a malfunction occurred 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 erroneous negative sars-cov-2 igg (access sars-cov-2 igg assay, part number c58961 and lot number 971197) were generated on the customer's unicel dxi 600 access immunoassay analyser (part number a30260 and serial number (b)(4)).The same sample had also generated a reactive result with the biosynex assay.The customer did not indicate whether the results were released from the laboratory.There was no report of change to patient treatment, or management in association with this event.System performance indicators such as system check, quality control and calibration were all passing within specifications at the time of the event.There were no hardware errors or other assay issues reported in conjunction with this event.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.The customer submitted sample to the complaint handling unit for further investigation.

• 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 ; 9523681224
• MDR Report Key: 10650140
• MDR Text Key: 210513121
• Report Number: 9680746-2020-00041
• 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: FR
• 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: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• 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
• Date Manufacturer Received: 09/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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