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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-CCP IMMUNOASSAY; ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)
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ROCHE DIAGNOSTICS ELECSYS ANTI-CCP IMMUNOASSAY; ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP) Back to Search Results
Catalog Number 05031656190
Device Problem Non Reproducible Results (4029)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/02/2019
Event Type  malfunction  
Manufacturer Narrative
This event occurred in (b)(6).Calibration has been performed and qc was acceptable.
 
Event Description
The initial reporter questioned results for 7 patients when tested for elecsys anti-ccp (anti-ccp) on a cobas e 601 module.Refer to attached data for the patient results.The results were reported outside of the laboratory and questioned by physicians.There was no allegation that an adverse event occurred.The e601 module serial number was (b)(4).
 
Manufacturer Narrative
The patient samples were not available for investigation.The data provided does not suggest a general reagent issue.A product problem was not identified.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-CCP IMMUNOASSAY
Type of Device
ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key8792548
MDR Text Key151124538
Report Number1823260-2019-02611
Device Sequence Number1
Product Code NHX
Combination Product (y/n)N
PMA/PMN Number
K081338
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 09/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number05031656190
Device Lot Number400794
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/25/2019
Initial Date FDA Received07/16/2019
Supplement Dates Manufacturer Received06/25/2019
Supplement Dates FDA Received09/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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