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

Catalog Number 09203079190

Device Problem False Negative Result (1225)

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

Event Date 05/26/2022

Event Type  malfunction  

Event Description

The initial reporter stated they received questionable negative results for seven patient samples tested with elecsys anti-sars-cov-2 on a cobas 8000 e 801 module (serial number (b)(4)).No incorrect results were reported outside of the laboratory.All seven patients had a history of covid-19 infection.All patients had positive polymerase chain reaction (pcr) test results 11 to 42 days prior to testing the patients with the elecsys anti-sars-cov-2 assay.The specific information/data for each patient/sample was not provided.For each individual patient, it is not known exactly how many days elapsed between pcr and elecsys anti-sars-cov-2 measurements.When tested on the e 801 analyzer, all seven samples had non-reactive results for elecsys anti-sars-cov-2.The results ranged between 0.3 coi and 0.9 coi.The reporter noted that the coi values for these measurements were higher than the coi for other negative samples, so a high dose hook effect was suspected.

Manufacturer Narrative

Per product labeling: "the sensitivity of the elecsys anti-sars-cov-2 assay early after infection is unknown.Negative results do not preclude acute sars-cov-2 infection.If acute infection is suspected, direct testing for sars-cov-2 is necessary." the investigation could not identify a product problem.A possible explanation would be that antibody titers have not yet developed to a detectable level in the elecsys anti-sars-cov-2 assay.The result distribution would be in line with this assumption as some individuals have shown enhanced, but non-reactive levels just below the cutoff value of 1 coi (range = 0.3-0.9 coi).Anti-nucleocapsid antibodies may also have a lower sensitivity in m-rna-vaccinees who later become infected.

Manufacturer Narrative

The component code has been updated.

• 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: 14779917
• MDR Text Key: 294544847
• Report Number: 1823260-2022-01810
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: EUA200514
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 09203079190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2022
• 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
• Patient Sequence Number: 1