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

Model Number E601

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 12/16/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys folate iii assay results for multiple patient samples with cobas 6000 e601 module.The following are examples of discrepant results for 5 patient samples: sample id (b)(6) the initial result was 4.33 ug/l.The repeated result was 2.36 ug/l.Sample id (b)(6) the initial result was 5.07 ug/l.The repeated result was 2.55 ug/l.Sample id (b)(6) the initial result was 4.65 ug/l.The repeated result was 2.50 ug/l.Sample id (b)(6) the initial result was 3.83 ug/l.The repeated result was 2.63 ug/l.Sample id (b)(6) the initial result was 3.31 ug/l.The repeated result was 2.46 ug/l.The questionable results were reported outside of the laboratory.The repeated results were deemed correct and correct reports were sent.The reagent lot number was 536855.The expiration date was requested but not provided.

Manufacturer Narrative

Upon review of the alarm trace, no issues were observed.The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with a reagent aspiration error caused by foam on the reagent pack which is related to handling of that reagent pack.

• 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: 13386428
• MDR Text Key: 295130843
• Report Number: 1823260-2022-00224
• Device Sequence Number: 1
• Product Code: CGN
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: E601
• Device Catalogue Number: 07559992190
• Device Lot Number: 53685502
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2022
• 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
• Patient Age: 56 YR
• Patient Sex: Female