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

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.

• 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 Key: 7697661
• MDR Text Key: 114287415
• Report Number: 1823260-2018-02374
• Device Sequence Number: 1
• Product Code: NIG
• UDI-Device Identifier: 04015630904297
• UDI-Public: 04015630904297
• Combination Product (y/n): N
• PMA/PMN Number: K050231
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11776193122
• Device Lot Number: 312851
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: 07/05/2018
• Supplement Dates FDA Received: 08/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1