MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-SARS-COV-2; CORONAVIRUS SEROLOGICAL REAGENT

Catalog Number 09203095190

Device Problem False Negative Result (1225)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

Calibrations for reagent lot 495464 gave reproducible results close to expected levels.The investigation could not identify a product problem.The cause of the event could not be determined.An issue arising from the sample may have been responsible for the initial low result.

Event Description

The initial reporter stated they received a discrepant result for one patient sample tested with the elecsys anti-sars-cov-2 reagent lot number 495464 on a cobas e 411 immunoassay analyzer.No incorrect results were reported outside of the laboratory.The sample was tested using elecsys anti-sars-cov-2 reagent lot number 494813, resulting with a value of 1.42 coi (reactive).The sample was tested using elecsys anti-sars-cov-2 reagent lot number 496298, resulting with a value of 1.30 coi (reactive).The sample was tested using elecsys anti-sars-cov-2 reagent lot number 495464, resulting with a value of 0.989 coi (non-reactive).Elecsys anti-sars-cov-2 reagent lot number 495464 was re-calibrated and the sample was repeated five times on (b)(6) 2020, resulting with the following values: 1.21 coi (reactive), 1.21 coi (reactive), 1.21 coi (reactive), 1.23 coi (reactive), and 1.24 coi (reactive).The serial number of the e411 analyzer is (b)(4).

• Brand Name: ELECSYS ANTI-SARS-COV-2
• Type of Device: CORONAVIRUS SEROLOGICAL REAGENT
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 10232534
• MDR Text Key: 198759791
• Report Number: 1823260-2020-01590
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• 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: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09203095190
• Device Lot Number: 495464
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1