MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FOLATE III; ACID, FOLIC, RADIOIMMUNOASSAY

Catalog Number 07559992190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that last year, they had a complaint concerning higher patient values obtained with folate iii (fol3) on a cobas 6000 analyzer.Patient values were higher when compared to values from an abbott architect analyzer.The abbott results were believed to be correct.No further details were provided regarding this previous issue.The fol3 reagent has since been re-standardized.The customer then continued to work with the new re-standardized reagent and had no issues.The customer has now called back reporting that they now continue to have issues with the assay.They state that when patient values recover over the measuring range and dilution of samples is required, the diluted sample result is too high when compared to results from the abbott analyzer.The customer provided an example for one patient sample that had an erroneous fol3 result which was reported outside of the laboratory.The sample initially resulted with a value over the measuring range and was accompanied by a data flag indicating as such.No specific value was provided for this result.The sample was manually diluted at a 1:2 dilution, then resulted with a final value of 32 ng/ml.The 32 ng/ml value was reported outside of the laboratory.The hematologist did not believe the result, so the sample was sent to another laboratory for testing on an abbott architect analyzer.The result from the abbott architect analyzer was 16.3 ng/ml.The customer stated that they believe that when they dilute samples, some kind of interference with the fol3 assay is involved.The patient was not adversely affected.The serial number of the cobas 6000 analyzer is (b)(4).

Manufacturer Narrative

The result from the abbott architect analyzer was confirmed to be 16.30 ug/l.The units of measure have been updated from ng/ml to ug/l.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.Additional information required for the investigation was requested, but not provided.A reagent issue can most likely be excluded based on the provided control data.Possible root causes may be related to the sample being hemolytic, evaporation effects on the sample, or the sample was from a patient who was not fasting.

• Brand Name: FOLATE III
• Type of Device: ACID, FOLIC, RADIOIMMUNOASSAY
• 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: 5778304
• MDR Text Key: 49074925
• Report Number: 1823260-2016-00875
• Device Sequence Number: 1
• Product Code: CGN
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K082340
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2016

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: 07559992190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 07/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 07/19/2016; 08/01/2016
• 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