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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FERRITIN; FERRITIN IMMUNOLOGICAL TEST SYSTEM
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ROCHE DIAGNOSTICS ELECSYS FERRITIN; FERRITIN IMMUNOLOGICAL TEST SYSTEM Back to Search Results
Catalog Number 04491785190
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/11/2020
Event Type  malfunction  
Manufacturer Narrative
Quality control results were all within specifications.The investigation is ongoing.This event occurred in (b)(6).
 
Event Description
The initial reporter received questionable elecsys ferritin results for two patient samples from cobas e411 rack analyzer serial number: (b)(4).Patient 1 initial result was 7.43 ng/ml.On (b)(6) 2020, the repeat result on a siemens system was 3.1 ng/ml.Patient 2 initial result on (b)(6) 2020 was 43.73 ng/ml.On (b)(6) 2020, the repeat result on a siemens system was 13.8 ng/ml.The questionable results were reported outside of the laboratory.
 
Manufacturer Narrative
As no sample material could be provided, the investigation did not identify a product problem.The cause of the event could not be determined.Based on the customer¿s calibration and qc data, a general reagent issue can most likely be excluded.
 
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Brand Name
ELECSYS FERRITIN
Type of Device
FERRITIN IMMUNOLOGICAL TEST SYSTEM
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key10525148
MDR Text Key229913353
Report Number1823260-2020-02199
Device Sequence Number1
Product Code JMG
Combination Product (y/n)N
PMA/PMN Number
K971833
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 10/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2021
Device Catalogue Number04491785190
Device Lot Number44979301
Was Device Available for Evaluation? Yes
Date Manufacturer Received08/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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