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

Catalog Number	07027559190
Medical Device Problem Codes	Incorrect Measurement (1383); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 1823260-2022-00915
• Device Sequence Number: 4163449
• Product Code: CFP
• UDI-Device Identifier: 04015630940042
• UDI-Public: 04015630940042
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K001104
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 04/14/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPART INSULIN; GLARGINE INSULIN
• Patient Age: 82 YR
• Patient Sex: Female