MAUDE Adverse Event Report: ROCHE DIAGNOSTICS CORTISOL; ENZYME IMMUNOASSAY, CORTISOL, SALIVARY

Catalog Number ASKU

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/16/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer stated that they performed a comparison study for 30 patient samples tested for cortisol and cortisol ii on an e170 analyzer.The customer was questioning results for one sample in particular, since there was a large result difference between the two assays.Of the provided data, a total of eleven patient samples had erroneous results that were reported outside of the laboratory for cortisol.The cortisol results were reported outside of the laboratory and the results from the cortisol ii assay were believed to be correct.The cortisol ii assay is not sold in the united states, nor is it like or similar to products sold in the united states.The first patient serum sample initially resulted as 13.7 ug/dl when tested with cortisol.The sample resulted as 8.95 ug/dl when tested with cortisol ii.The second patient serum sample initially resulted as 10.3 ug/dl when tested with cortisol on (b)(6) 2016.The sample resulted as 5.42 ug/dl when tested with cortisol ii.The third patient serum sample initially resulted as 16.78 ug/dl when tested with cortisol on (b)(6) 2016.The sample resulted as 10.85 ug/dl when tested with cortisol ii.The fourth patient saliva sample initially resulted as 2.96 ng/ml when tested with cortisol on (b)(6) 2016.The sample resulted as 0.54 ug/dl when tested with cortisol ii.The fifth patient saliva sample initially resulted as 6.73 ng/ml when tested with cortisol on (b)(6) 2016.The sample resulted as 2.8 ug/dl when tested with cortisol ii.The sixth patient saliva sample initially resulted as 4.13 ng/ml when tested with cortisol on (b)(6) 2016.The sample resulted as 1.7 ug/dl when tested with cortisol ii.The seventh patient saliva sample initially resulted as 3.67 ng/ml when tested with cortisol on (b)(6) 2016.The sample resulted as 1.78 ug/dl when tested with cortisol ii.The eighth patient saliva sample initially resulted as 5.67 ng/ml when tested with cortisol on (b)(6) 2016.The sample resulted as 2.59 ug/dl when tested with cortisol ii.The ninth patient saliva sample initially resulted as 14.7 ng/ml when tested with cortisol on (b)(6) 2016.The sample resulted as 9.49 ug/dl when tested with cortisol ii.The tenth patient serum sample initially resulted as 25.45 ug/dl when tested with cortisol on (b)(6) 2016.The sample resulted as 16.34 ug/dl when tested with cortisol ii.The eleventh patient serum sample initially resulted as 27.24 ug/dl when tested with cortisol on (b)(6) 2016.The sample resulted as 17.61 ug/dl when tested with cortisol ii.The patients were not adversely affected.The e170 analyzer serial number was asked for, but not provided.Investigations have determined that an old cortisol calibration was in use at the time of the event.No general reagent issue was detected.

Manufacturer Narrative

Investigations state that with the launch of the cortisol ii assay, the formerly used polyclonal antibody was replaced by a monoclonal antibody, which is more specific and shows a lower cross-reactivity profile.The cortisol ii assay is also standardized against different reference material, which ensures accurate results.This standardization is the reason that a shift in patient results will be observed when switching from cortisol to cortisol ii.

• Brand Name: CORTISOL
• Type of Device: ENZYME IMMUNOASSAY, CORTISOL, SALIVARY
• 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: 5532911
• MDR Text Key: 41427478
• Report Number: 1823260-2016-00368
• Device Sequence Number: 1
• Product Code: NHG
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K070788
• 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,Followup
• Report Date: 04/07/2016

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: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2016
• Initial Date FDA Received: 03/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/08/2016
• 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