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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
Model Number N/A
Device Problem False Positive Result (1227)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/04/2020
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete. This report is being filed on an international product, list number 6c29 that has a similar product distributed in the us, list number 6l27.
 
Event Description
The customer reported false reactive architect (b)(6) results for a female patient. The following data was provided (reference range: less than 1. 00
=
nonreactive, greater than or equal to 1. 00 s/co
=
reactive): on (b)(6) 2020 sid (b)(6)
=
initial
=
1. 03 s/co (reactive), repeat
=
1. 15 s/co (reactive). On (b)(6) 2020 sid (b)(6)
=
(b)(6) virus ab igg (cmia)
=
negative (outside lab). On (b)(6) 2020 sid (b)(6)
=
1. 06 s/co (reactive) (after re-calibrating).
 
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Brand NameARCHITECT HAVAB-IGG
Type of DeviceHAVAB-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 Key10482204
MDR Text Key233891387
Report Number3002809144-2020-00882
Device Sequence Number1
Product Code LOL
Combination Product (y/n)N
Reporter Country CodeHK
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 09/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/27/2020
Device Model NumberN/A
Device Catalogue Number06C29-27
Device Lot Number11530BE00
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 Received09/10/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/09/2020
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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