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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS C-PEPTIDE C-PEPTIDES OF PROINSULIN TEST SYSTEM

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ROCHE DIAGNOSTICS ELECSYS C-PEPTIDE C-PEPTIDES OF PROINSULIN TEST SYSTEM Back to Search Results
Catalog Number 03184897190
Device Problem High Test Results (2457)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/14/2020
Event Type  malfunction  
Manufacturer Narrative
Phone (b)(6). This event occurred in (b)(6). The investigation is ongoing.
 
Event Description
The initial reporter received questionable elecsys c-peptide results for one patient tested on a cobas 8000 e 602 module serial number: (b)(4). The customer also performed testing on a siemens immulite 2000 analyzer to compare results and to detect any sample or reagent interferences. The questionable results were reported outside the laboratory. Refer to the attachment for all patient data. This medwatch is for elecsys c-peptide. Refer to medwatch with patient identifier: (b)(6) for the elecsys insulin assay.
 
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Brand NameELECSYS C-PEPTIDE
Type of DeviceC-PEPTIDES OF PROINSULIN 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 Key10515500
MDR Text Key231226257
Report Number1823260-2020-02232
Device Sequence Number1
Product Code JKD
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03184897190
Device Lot NumberASKU
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2020
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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