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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HAVAB-IGG

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ABBOTT GMBH ARCHITECT HAVAB-IGG Back to Search Results
Catalog Number 06C29-22
Device Problem False Positive Result (1227)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/14/2019
Event Type  malfunction  
Manufacturer Narrative
This issue is also being reported under mdr numbers 3002809144-2019-00866 and 3002809144-2019-00868 for two additional suspect devices, list 06c29-22, lot 01244be00 and lot 94521li00, respectively. An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported false reactive havab igg results when processing on the architect i2000sr. No specific patient information was provided. No impact to patient management was reported.
 
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Brand NameARCHITECT HAVAB-IGG
Type of DeviceARCHITECT HAVAB-IGG
Manufacturer (Section D)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer (Section G)
ABBOTT GMBH
max-planck-ring 2
wiesbaden 65205
GM 65205
Manufacturer Contact
christian lee
100 abbott park road
dept 09b9, bldg cp01-3
abbott park, IL 60064-3537
224668-294
MDR Report Key9315278
MDR Text Key219783141
Report Number3002809144-2019-00867
Device Sequence Number1
Product Code LOL
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/13/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/22/2019
Device Catalogue Number06C29-22
Device Lot Number95381LI00
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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