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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS C-PEPTIDE C-PEPTIDE IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY

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ROCHE DIAGNOSTICS ELECSYS C-PEPTIDE C-PEPTIDE IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY Back to Search Results
Catalog Number 07027168190
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2021
Event Type  malfunction  
Manufacturer Narrative
The customer treated and tested the sample by precipitation by polyethylene glycol (peg) on the e801 module. The insulin result after peg treatment was 125 uu/ml. The c-peptide result after peg treatment was 4. 04 ng/ml. The customer also performed a dilution experiment on the e801 module: c-peptide with 1:2 dilution was 21. 1 ng/ml; final result was 42. 2 ng/ml. C-peptide with 1:4 dilution was 12. 1 ng/ml; final result was 48. 4 ng/ml. C-peptide with 1:16 dilution was 4. 80 ng/ml; final result was 76. 8 ng/ml. Insulin with 1:16 dilution was 105 uu/ml; final result was 1680 uu/ml. The sample was requested for investigation.
 
Event Description
The initial reporter complained of discrepant results for 1 patient sample tested for elecsys insulin (insulin) and elecsys c-peptide (c-peptide) on a cobas e801 module compared to the beckman method. This medwatch will cover c-peptide. Refer to medwatch with a1 patient identifier pt-59788 for information on the insulin results. The initial insulin result from the e801 module was 1000 uu/ml with a data flag. The initial c-peptide result from the e801 module was 34. 9 ng/ml. The results were reported outside of the laboratory where they were questioned by the doctor. On (b)(6) 2021 the sample was sent to an external laboratory using the beckman method and the insulin result was 136. 13 uu/ml and the c-peptide result was 20. 35 ng/ml. The customer does not know which results are correct and suspects an interference. The e801 module serial number was not provided.
 
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Brand NameELECSYS C-PEPTIDE
Type of DeviceC-PEPTIDE IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY
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 Key12342278
MDR Text Key267269389
Report Number1823260-2021-02416
Device Sequence Number1
Product Code JKD
UDI-Device Identifier04015630939992
UDI-Public04015630939992
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
EXEMPT
Number of Events Reported1
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 11/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number07027168190
Device Lot Number51737001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/04/2021
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
Type of Device Usage Invalid Data

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