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

Catalog Number 11875116122

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2015

Event Type  malfunction  

Event Description

The customer reported that they received questionable results for a total of 28 patient saliva samples tested for cortisol.The samples were being tested as part of a lot to lot correlation on the e601 analyzer.Of the 28 samples, fourteen were found to have erroneous results that were reported outside of the laboratory.The results obtained with the current reagent lot number 178322 were high compared to results from the new reagent lot number 185380.The customer stated that they had noticed with increased frequency that controls were outside of range and patient results had been increasing.The results obtained with the current lot 178322 were reported outside of the laboratory.The results obtained with new lot 185380 were believed to be correct.The pathologist did not deem the difference in results to be clinically significant, so the results that had been reported outside of the laboratory were not corrected.The first patient sample resulted as 0.396 ug/dl when tested with the current lot and resulted as 0.241 ug/dl when tested with the new lot.The second patient sample resulted as 0.353 ug/dl when tested with the current lot and resulted as 0.203 ug/dl when tested with the new lot.The third patient sample resulted as 0.286 ug/dl when tested with the current lot and resulted as 0.176 ug/dl when tested with the new lot.The fourth patient sample resulted as 0.864 ug/dl when tested with the current lot and resulted as 0.546 ug/dl when tested with the new lot on (b)(6) 2015.This patient was a (b)(6).The fifth patient sample resulted as 0.140 ug/dl when tested with the current lot and resulted as 0.018 ug/dl when tested with the new lot on (b)(6) 2015.The sixth patient sample resulted as 0.222 ug/dl when tested with the current lot and resulted as 0.071 ug/dl when tested with the new lot on (b)(6) 2015.The seventh patient sample resulted as 0.483 ug/dl when tested with the current lot and resulted as 0.232 ug/dl when tested with the new lot on (b)(6) 2015.The eighth patient sample resulted as 63.44 ug/dl when tested with the current lot and resulted as 39.30 ug/dl when tested with the new lot on (b)(6) 2015.The ninth patient sample resulted as 0.191 ug/dl when tested with the current lot and resulted as 0.037 ug/dl when tested with the new lot on (b)(6) 2015.The tenth patient sample resulted as 0.452 ug/dl when tested with the current lot and resulted as 0.256 ug/dl when tested with the new lot on (b)(6) 2015.The eleventh patient sample resulted as 0.297 ug/dl when tested with the current lot and resulted as 0.183 ug/dl when tested with the new lot on (b)(6) 2015.The twelfth patient sample resulted as 0.300 ug/dl when tested with the current lot and resulted as 0.157 ug/dl when tested with the new lot on (b)(6) 2015.The thirteenth patient sample resulted as 0.774 ug/dl when tested with the current lot and resulted as 0.485 ug/dl when tested with the new lot on (b)(6) 2015.The fourteenth patient sample resulted as 0.164 ug/dl when tested with the current lot and resulted as 0.020 ug/dl when tested with the new lot on (b)(6) 2015.The patients were not adversely affected.The e601 analyzer serial number was (b)(4).The field service representative determined that the issue was caused by the older, current reagent lot number.The customer switched to the new lot number.Calibration and controls passed according to the customer's ranges.The field application specialist determined that the older, current lot was not recovering as expected.The new lot number was recovering within acceptable limits.

Manufacturer Narrative

A specific root cause could not be determined based on the provided information.Calibration effects are considered to contribute to the customer observed initial lot deviation.Both reagent lots showed higher than expected recovery for one of the calibrators.The quality control recovery trend was found to contradict the findings of the patient sample comparison.Internal method comparison data shows excellent agreement between the reagent lots in question.

• Brand Name: CORTISOL
• Type of Device: ENZYME IMMUNOASSAY, CORTISOL, SALIVARY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• 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: 5107564
• MDR Text Key: 26882565
• Report Number: 1823260-2015-04226
• Device Sequence Number: 1
• Product Code: NHG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070788
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date: 10/23/2015

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 Expiration Date: 10/31/2015
• Device Catalogue Number: 11875116122
• Device Lot Number: 17832201
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2015
• 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