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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HAVAB-G IGG ANTI-HAV

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ABBOTT GMBH ARCHITECT HAVAB-G IGG ANTI-HAV 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 07/07/2020
Event Type  malfunction  
Manufacturer Narrative
An evaluation is in process. A follow-up report will be submitted when the evaluation is complete.
 
Event Description
The customer reported false reactive architect (b)(6) results on multiple patients. The following data was provided (reference range: < 1. 0 s/co
=
nonreactive, >
=
1. 00 s/co
=
reactive): patient #1
=
1. 05 s/co (old), 0. 31 s/co (new); patient #2
=
1. 09 s/co (old), 0. 62 s/co (new); patient #3
=
1. 52 s/co (old), 0. 62 s/co (new); patient #4
=
1. 19 s/co (old), 0. 39 s/co (new); patient #5
=
1. 05 s/co (old), 0. 30 s/co (new); patient #6
=
1. 61 s/co (old), 0. 48 s/co (new); patient #7
=
1. 56 s/co (old), 0. 53 s/co (new). The initial (b)(6) results with the old lot are reactive, repeat results using the new lot are nonreactive. There was no impact to patient management reported.
 
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Brand NameARCHITECT HAVAB-G
Type of DeviceIGG ANTI-HAV
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 Key10335032
MDR Text Key233891086
Report Number3002809144-2020-00749
Device Sequence Number1
Product Code LOL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/02/2020
Device Model NumberN/A
Device Catalogue Number06L27-25
Device Lot Number12026BE00
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 Received09/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/11/2019
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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