MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS TACROLIMUS; TACROLIMUS ENZYME IMMUNOASSAY

Model Number E411 RACK

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 06/26/2023

Event Type  malfunction  

Manufacturer Narrative

The reagent lot number is 688746.The expiration date was requested but not provided.The investigation is ongoing.

Event Description

The initial reporter received questionable elecsys tacrolimus assay results from multiple patient samples tested on the cobas e411 rack.The initial result was not reported outside of the laboratory.The reporter stated that they have an ongoing issue with the tacrolimus assay.They are running the patient samples on both of their e 411 analyzers.Please refer to the attachment pt-83173 in the medwatch for the table containing examples of questionable results and the results reported outside of the laboratory.

Manufacturer Narrative

Medwatch fields d device identification d1-d4 updated.The investigation reviewed the data of the last calibration performed on 22-jun-2023; the signals were within specifications.The investigation reviewed the alarm trace; no issues were noted.The field application specialist (fas) observed the customer's staff technologists pretreating sample procedures; there were no issues noted.The field service representative (fsr) inspected the analyzer and determined that the event was caused by external factors affecting multiple instruments.The customer performed a patient correlation study between their analyzers with successful results.After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• Brand Name: ELECSYS TACROLIMUS
• Type of Device: TACROLIMUS ENZYME IMMUNOASSAY
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250-0457 ; 3174767531
• MDR Report Key: 17363151
• MDR Text Key: 319486055
• Report Number: 1823260-2023-02378
• Device Sequence Number: 1
• Product Code: MLM
• UDI-Device Identifier: 04015630947102
• UDI-Public: 04015630947102
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173857
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E411 RACK
• Device Catalogue Number: 05889057160
• Device Lot Number: 688746
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• 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