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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-SARS-COV-2; CORONAVIRUS SEROLOGICAL REAGENT
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ROCHE DIAGNOSTICS ELECSYS ANTI-SARS-COV-2; CORONAVIRUS SEROLOGICAL REAGENT Back to Search Results
Catalog Number 09203095190
Device Problem False Negative Result (1225)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/03/2020
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).The investigation is ongoing.
 
Event Description
The initial reporter received questionable elecsys anti-sars-cov-2 results for 2 patients on a cobas 6000 e601 module.The analyzer's serial number was requested, but not provided.The sample for patient 1 produced a negative result of 0.426 coi.The sample for patient 2 (female) produced a negative result of 0.268 coi.It is not known if either of the negative results were reported outside of the laboratory.
 
Manufacturer Narrative
The calibration was successful on (b)(6) 2020.The investigation found that the customer results were reproducible with both patient samples.A rapid assay from creative diagnostics and an independent in-house roche assay showed reactive results.The low viral load is well in line with a low immune response to the viral antigen used in the assay.Based on the available data, a general reagent issue could be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.
 
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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
MDR Report Key10205746
MDR Text Key200065111
Report Number1823260-2020-01560
Device Sequence Number1
Product Code QKO
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 08/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number09203095190
Device Lot Number496298
Was Device Available for Evaluation? Yes
Date Manufacturer Received06/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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