MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS AFP ASSAY; KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER

Model Number AFP

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

The reporter cleaned and primed the sample probe.After this, controls were measured with the complained reagent pack.No alarms occurred, but measurement results were all < 0.605 ng/ml.The investigation could not identify a product problem.The cause of the event could not be determined.This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for two patient samples tested with the elecsys afp assay on a cobas e 411 immunoassay analyzer.It was asked, but it is not known if any incorrect values were reported outside of the laboratory.A sample probe alarm was generated when using the afp reagent pack and samples were remeasured after replacement of the pack.The repeat values were believed to be correct.The first sample initially resulted with an afp value of < 0.605 ng/ml and upon repeat, the sample resulted with a value of 6.29 ng/ml.The second sample initially resulted with an afp value of < 0.605 ng/ml and upon repeat, the sample resulted with a value of 2.88 ng/ml.The e 411 analyzer serial number is (b)(4).

• Brand Name: ELECSYS AFP ASSAY
• Type of Device: KIT, TEST,ALPHA-FETOPROTEIN FOR TESTICULAR CANCER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 9526135
• MDR Text Key: 219778606
• Report Number: 1823260-2019-04552
• Device Sequence Number: 1
• Product Code: LOJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K981282
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AFP
• Device Catalogue Number: 04481798190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1