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

Model Number E601

Device Problems Failure to Recalibrate (1517); Failure to Calibrate (2440); High Test Results (2457); High Readings (2459); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2022

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for nine patient samples tested with the elecsys folate iii assayver.2 on a cobas 6000 e 601 module.Refer to the attachment for all patient data.The initial values were reported outside of the laboratory to the corresponding doctor for all samples except the samples with identifiers of (b)(6).Corrected reports were issued for the repeat values.The folate reagent lot number was 596881.The reagent expiration date was requested, but not provided.

Manufacturer Narrative

The customer has updated the patient data and the correct initial values have been provided.Relevant test data for some of the patient samples was also provided.See attachment for all patient data.The repeat values for sample ids 90194 and 90195 were measured on 20-may-2022.All other values were measured on 19-may-2022.Calibration data from 25-mar-2022 to 19-may-2022 was provided for folate reagent lot 596881.The calibration signals were lower than expected and were decreasing over time.From the calibration data, it was not evident if some calibrations failed, but failed calibrations were suggested according to the customer's comments and the provided quality control data.Quality control data from 10-apr-2022 to 24-may-2022 was provided.Most values were within acceptable ranges, however there were several out of range high values for all control levels.Several control measurements performed with all control levels were outside of range on the day of the event.Two levels of control were not measured on 18-may-2022; only one level of control was measured that day and it was within range.Per product labeling: "controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per reagent kit, and following each calibration.The control intervals and limits should be adapted to each laboratory¿s individual requirements.Values obtained should fall within the defined limits.Each laboratory should establish corrective measures to be taken if values fall outside the defined limits.If necessary, repeat the measurement of the samples concerned." it is unknown how the samples were stored in between initial and repeat measurements.Per product labeling, the stability of folate at room temperature (15-25 degrees celsius) is only 2 hours.All samples were initially processed on a modular pre-analytics system prior to testing.Investigations have confirmed a signal loss for folate reagent lot 596881.It is very likely this issue contributed to the observed sample discrepancies at the customer site.

• Brand Name: ELECSYS 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: 14675980
• MDR Text Key: 298120950
• Report Number: 1823260-2022-01710
• Device Sequence Number: 1
• Product Code: CGN
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K082340
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E601
• Device Catalogue Number: 07559992190
• Device Lot Number: 596881
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2022
• 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
• Patient Sequence Number: 1