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 03/28/2022

Event Type  malfunction  

Manufacturer Narrative

Qc was within range on the day of the event.On (b)(6) 2022 the customer performed dilution testing on the sample and the results from the e801 unit were: 1:2 dilution result >1000 uu/ml; 1:4 dilution result >1000 uu/ml; 1:8 dilution result >1000 uu/ml; 1:16 dilution result 875 uu/ml with a final result of 14000 uu/ml; 1:32 dilution result 465 uu/ml with a final result of 14880 uu/ml; 1:64 dilution result 237 uu/ml with a final result of 15168 uu/ml; 1:128 dilution result 113 uu/ml with a final result of 14464 uu/ml.On (b)(6) 2022 the customer treated the sample by polyethylene glycol precipitation (peg) to test for an interference and the insulin result from the e801 unit was >1000 uu/ml.The customer took a different patient sample to see if peg treatment worked.The initial insulin result was 39.8 uu/ml; the result after peg was 19.0 uu/ml.A new sample was obtained from the patient on (b)(6) 2022 and the anti-insulin, anti-islet cell and anti-glutamate decarboxylase antibodies results were all negative.The patient was retested multiple times both in a fasting state and postprandial for insulin, glu and cp with the following results: the insulin results from the e801 unit were: fasting:>1000 uu/ml normal reference range (2.6-24.9 uu/ml); after meal 0.5 h: >1000 uu/ml; after meal 1.0 h: >1000 uu/ml; after meal 2.0 h: >1000 uu/ml; after meal 3.0 h: >1000 uu/ml.The cp results from the e801 unit were: fasting: 10.87 nmol/l normal reference range (0.37-1.47 nmol/l); after meal 0.5 h: 11.33 nmol/l; after meal 1.0 h: 11.17 nmol/l; after meal 2.0 h: 10.7 nmol/l; after meal 3.0 h: 11.73 nmol/l.The glu results from an unspecified, non-roche method were: fasting: 3.8 nmol/l normal reference range (3.9-6.1nmol/l); after meal 0.5 h: 10.7 nmol/l; after meal 1.0 h: 15.3 nmol/l normal reference range (6.7-11.1 nmol/l); after meal 2.0 h: 20.5 nmol/l normal reference range (3.9-7.8 nmol/l); after meal 3.0 h: 16.3 nmol/l normal reference range (3.9-7.8 nmol/l).The patient sample was requested for investigation.

Event Description

The initial reporter complained of a discrepant high result for 1 patient sample tested for elecsys insulin (insulin) on a cobas e 801 analytical unit compared to the siemens method.The 2 hour post-prandial result from the e801 unit was >1000 uu/ml.The sample was tested by the siemens method with a result of 101 uiu/ml.The questionable result was reported outside of the laboratory.The e801 unit serial number was (b)(4).

Manufacturer Narrative

Calibration signals from (b)(6) 2022 were within specification.The sample was not available for further investigation.A general reagent issue can be excluded as the quality validation data provided was within the expected range.The investigation did not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

Section a2, age was updated.On (b)(6)-2022 a new sample from the patient was tested.The fasting insulin result from the e801 module was >1000 uu/ml.The repeat test was >1000 uu/ml.The patient's fasting c-peptide result was 6.77 nmol/l.These results were reported outside of the laboratory to the same doctor from the initial event that was familiar with the patient.Calibration and qc were acceptable.No instrument issues were identified.The sample was requested for investigation, however, the patient sample is no longer available for further investigation.A general reagent problem can be excluded as the quality validation data provided was within expectations.The high insulin results are consistent with higher insulin production; this is supported by the elevated c-peptide result and the presence of anti-insulin antibodies recognized by the elecsys insulin assay.The investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 14193593
• MDR Text Key: 299087951
• Report Number: 1823260-2022-01165
• Device Sequence Number: 1
• Product Code: CFP
• UDI-Device Identifier: 04015630940042
• UDI-Public: 04015630940042
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 07027559190
• Device Lot Number: 584531
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• 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: 81 YR
• Patient Sex: Male