MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS INSULIN; IMMUNOREACTIVE INSULIN TEST SYSTEM

Catalog Number 07027559190

Device Problems Incorrect Measurement (1383); High Test Results (2457)

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

Event Date 02/07/2022

Event Type  malfunction  

Manufacturer Narrative

The customer tested the sample using polyethylene glycol (peg) procedure and the insulin result from the e801 module was 77.48 uu/ml and the result from the abbott method was 297 uu/ml.Anti-insulin antibodies >50 u/ml were made.

Event Description

The initial reporter questioned results for 1 patient sample tested for elecsys insulin (insulin) on a cobas e801 module.The initial insulin result from the e801 module was >1000 (the unit of measure was not provided).The repeat result with a 1:20 dilution from the e801 module was 3760.The repeat result with a 1:40 dilution from the e801 module was 3856.The sample was tested by the abbott method and the result from an unspecified dilution was 8024 (the unit of measure was not provided).No questionable results were reported outside of the laboratory.The e801 module serial number was 1743-03.

Manufacturer Narrative

Section b3, date of event was updated.Section d4, lot number and expiration date were updated.The insulin unit of measure on the e801 module was uu/ml.The unit of measure for the abbott result of 8024 was uu/ml.Calibration and qc were acceptable.The high roche results are explained by the anti-insulin antibodies identified by the customer in the patient sample.The higher dilution result from the abbott method shows the same clinical picture of elevated insulin concentrations.Roche does not recommend dilution for samples tested for insulin.Under the dilution section in product labeling: "not necessary due to the broad measuring range." the patient has diabetes and takes glargine and aspart insulin.Product labeling states: "insulin lispro, insulin aspart, and insulin glargine were each tested in concentrations of 30, 100, 300, and 1000 miu/l in the absence of insulin.The results obtained were below the detection limit of the elecsys insulin assay (< 0.4 ¿u/ml or < 2.78 pmol/l) at all the concentrations tested." a general reagent problem can be excluded as all qc data was within specification.The investigation did not identify a product problem.

• Brand Name: ELECSYS INSULIN
• Type of Device: IMMUNOREACTIVE INSULIN TEST SYSTEM
• 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: 13963466
• MDR Text Key: 297734415
• Report Number: 1823260-2022-00915
• Device Sequence Number: 1
• Product Code: CFP
• UDI-Device Identifier: 04015630940042
• UDI-Public: 04015630940042
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: K001104
• 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: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 07027559190
• Device Lot Number: 529408
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2022
• 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
• Treatment: ASPART INSULIN; GLARGINE INSULIN
• Patient Age: 82 YR
• Patient Sex: Female