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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS AMYL2 LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES

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ROCHE DIAGNOSTICS AMYL2 LIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES Back to Search Results
Catalog Number 03183742122
Device Problem High Test Results (2457)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/18/2022
Event Type  malfunction  
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Brand NameAMYL2
Type of DeviceLIPASE HYDROLYSIS/GLYCEROL KINASE ENZYME, TRIGLYCERIDES
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 Key14137519
Report Number1823260-2022-01091
Device Sequence Number1
Product Code CDT
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K972250
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 06/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number03183742122
Device Lot Number57734201
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/10/2022
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
Type of Device Usage Invalid Data

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