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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS CA 19-9 IMMUNOASSAY; TEST, CARBOHYDRATE ANTIGEN (CA19-9)

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ROCHE DIAGNOSTICS ELECSYS CA 19-9 IMMUNOASSAY; TEST, CARBOHYDRATE ANTIGEN (CA19-9) Back to Search Results
Catalog Number 11776193122
Device Problem Low Test Results (2458)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/05/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
The customer questioned low results using 1 particular reagent bottle when testing patients for elecsys ca 19-9 immunoassay (ca 19-9) on an elecsys e170 modular analytics immunoassay analyzer.On (b)(6) 2018 the customer got a ca 19-9 result of < 0.600 u/ml.The customer changed to a new reagent bottle with the same lot number and a result within the measuring range was obtained.The actual result was not provided.Afterwards, the customer switched back to the original reagent bottle.On (b)(6) 2018 the customer got a ca 19-9 result with the original reagent bottle.The result on (b)(6) 2018 was within the measuring range.The actual result was not provided.On (b)(6) 2018 six patient samples were tested for ca 19-9 and repeated.Of these 6 patient samples, the results for 1 patient sample were discrepant.The initial result was < 0.6 u/ml.The repeat result was 25.2 u/ml.No alarms were generated with the low result.The incorrect result was not reported outside of the laboratory.There was no allegation that an adverse event occurred.The e 170 analyzer serial number was (b)(4).The customer stated there were 30 tests remaining the reagent bottle in question.They started using it at the end of (b)(6) 2018.
 
Manufacturer Narrative
The issue was solved when the customer switched to a new reagent pack from the same reagent lot.A general reagent issue can be excluded.The investigation was unable to determine a definitive root cause.
 
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Brand Name
ELECSYS CA 19-9 IMMUNOASSAY
Type of Device
TEST, CARBOHYDRATE ANTIGEN (CA19-9)
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
MDR Report Key7697661
MDR Text Key114287415
Report Number1823260-2018-02374
Device Sequence Number1
Product Code NIG
UDI-Device Identifier04015630904297
UDI-Public04015630904297
Combination Product (y/n)N
PMA/PMN Number
K050231
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 08/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number11776193122
Device Lot Number312851
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/05/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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